Quality Manager - Analytical

Job Summary

Required Qualifications

• •Bachelor of Science Degree in the Biological Sciences, Bioengineering or Chemistry
• •Master's degree preferred
• •A minimum of 8+ years of experience performing quality control activities in the pharmaceutical and biotech industry under GMP guidelines
• •A minimum of 5+ years of GMP operations experience in the manufacture of for drugs substances / drug products
• •A minimum of 3+ years supervisory experience
• •Percentage of Travel: 5%
• •Strong communication skills, both written and verbal in the English language
• •outstanding interpersonal skills
• •excellent documentation skills
• •High attention to detail
• •highly organized
• •Ability to be self-motivated, proactive, accountable, and flexible
• •Ability to work well under pressure
• •Ability to handle multiple tasks/projects and meet deadlines
• •Strong scientific, analytical, and problem-solving skills
• •sound judgment
• •Ability to provide support for regulatory and client audits
• •Ability to interact with clients
• •Ability to develop staff to improve individual and departmental performance
• •Ability to manage a team and work independently on projects
• •Ability to review project data and provide summary analysis reports based upon the data
• •Ability to exercise sound judgment within defined procedures and policies to determine appropriate action
• •Ability to identify problems and lead efforts to resolve them
• •Ability to set stretch goals and link them to strategic outcomes and business deliverables
• •Ability to provide open communication
• •Ability to exemplify effective teamwork skills
• •Ability to develop and maintain Quality QC systems
• •Ability to achieve organizational objectives through the coordinated achievements of subordinate staff
• •Ability to establish departmental goals and objectives and function with autonomy
• •Ability to manage the accountability and stewardship of human, financial, and often physical resources
• •Ability to ensure subordinate supervisors and professionals adhere to defined internal controls
• •Ability to manage systems and procedures to protect departmental assets
• •Ability to demonstrate experience in leadership
• •Ability to develop a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives
• •Experience in the development and establishment of operations of QC laboratories in a GMP regulated environment
• •In-depth experience related to method development, optimization, validation, and tech transfers
• •Ability to manage a team and work independently on projects
• •Ability to review project data and provide summary analysis reports based upon the data
• •Ability to provide support for regulatory and client audits
• •Ability to interact with clients
• •A profound understanding of analytical instrument principals and application of advance instrumentation analysis for pharmaceutical and biologic products
• •Familiarity with analytical testing procedures: AGE, qPCR/dPCR, HPLC (IEX, RP, SEC), Sequencing, Plate Based Assays (BCA, Kanamycin)
• •Strong knowledge of pharmacopeia (USP/EP) and regulatory requirements for the industry (ICH, GDP, cGMP and quality systems including OOS investigations, deviations and CAPAs)
• •Strong leadership and motivational capabilities
• •Ability to work well under pressure
• •Ability to handle multiple tasks/projects and meet deadlines
• •High attention to detail
• •highly organized
• •excellent documentation skills
• •Strong communication skills, both written and verbal in the English language
• •outstanding interpersonal skills
• •excellent documentation skills
• •Ability to be self-motivated, proactive, accountable, and flexible
• •Ability to work well under pressure
• •Ability to handle multiple tasks/projects and meet deadlines
• •High attention to detail
• •highly organized
• •excellent documentation skills
• •Strong communication skills, both written and verbal in the English language
• •outstanding interpersonal skills
• •excellent documentation skills
• •High attention to detail
• •highly organized
• •Ability to be self-motivated, proactive, accountable, and flexible
• •Ability to work well under pressure
• •Ability to handle multiple tasks/projects and meet deadlines
• •Strong scientific, analytical, and problem-solving skills
• •sound judgment
• •Ability to provide support for regulatory and client audits
• •Ability to interact with clients
• •Ability to develop staff to improve individual and departmental performance
• •Ability to manage a team and work independently on projects
• •Ability to review project data and provide summary analysis reports based upon the data
• •Ability to exercise sound judgment within defined procedures and policies to determine appropriate action
• •Ability to identify problems and lead efforts to resolve them
• •Ability to set stretch goals and link them to strategic outcomes and business deliverables
• •Ability to provide open communication
• •Ability to exemplify effective teamwork skills
• •Ability to develop and maintain Quality QC systems
• •Ability to achieve organizational objectives through the coordinated achievements of subordinate staff
• •Ability to establish departmental goals and objectives and function with autonomy
• •Ability to manage the accountability and stewardship of human, financial, and often physical resources
• •Ability to ensure subordinate supervisors and professionals adhere to defined internal controls
• •Ability to manage systems and procedures to protect departmental assets
• •Ability to demonstrate experience in leadership
• •Ability to develop a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives
• •Experience in the development and establishment of operations of QC laboratories in a GMP regulated environment
• •In-depth experience related to method development, optimization, validation, and tech transfers
• •Ability to manage a team and work independently on projects
• •Ability to review project data and provide summary analysis reports based upon the data
• •Ability to provide support for regulatory and client audits
• •Ability to interact with clients
• •A profound understanding of analytical instrument principals and application of advance instrumentation analysis for pharmaceutical and biologic products
• •Familiarity with analytical testing procedures: AGE, qPCR/dPCR, HPLC (IEX, RP, SEC), Sequencing, Plate Based Assays (BCA, Kanamycin)
• •Strong knowledge of pharmacopeia (USP/EP) and regulatory requirements for the industry (ICH, GDP, cGMP and quality systems including OOS investigations, deviations and CAPAs)
• •Strong leadership and motivational capabilities
• •Ability to work well under pressure
• •Ability to handle multiple tasks/projects and meet deadlines
• •High attention to detail
• •highly organized
• •excellent documentation skills
• •Strong communication skills, both written and verbal in the English language
• •outstanding interpersonal skills
• •excellent documentation skills
• •Ability to be self-motivated, proactive, accountable, and flexible
• •Ability to work well under pressure
• •Ability to handle multiple tasks/projects and meet deadlines
• •Strong scientific, analytical, and problem-solving skills
• •sound judgment
• •Ability to provide support for regulatory and client audits
• •Ability to interact with clients
• •Ability to develop staff to improve individual and departmental performance
• •Ability to manage a team and work independently on projects
• •Ability to review project data and provide summary analysis reports based upon the data
• •Ability to exercise sound judgment within defined procedures and policies to determine appropriate action
• •Ability to identify problems and lead efforts to resolve them
• •Ability to set stretch goals and link them to strategic outcomes and business deliverables
• •Ability to provide open communication
• •Ability to exemplify effective teamwork skills
• •Ability to develop and maintain Quality QC systems
• •Ability to achieve organizational objectives through the coordinated achievements of subordinate staff
• •Ability to establish departmental goals and objectives and function with autonomy
• •Ability to manage the accountability and stewardship of human, financial, and often physical resources
• •Ability to ensure subordinate supervisors and professionals adhere to defined internal controls
• •Ability to manage systems and procedures to protect departmental assets
• •Ability to demonstrate experience in leadership
• •Ability to develop a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives
• •Experience in the development and establishment of operations of QC laboratories in a GMP regulated environment
• •In-depth experience related to method development, optimization, validation, and tech transfers
• •Ability to manage a team and work independently on projects
• •Ability to review project data and provide summary analysis reports based upon the data
• •Ability to provide support for regulatory and client audits
• •Ability to interact with clients
• •A profound understanding of analytical instrument principals and application of advance instrumentation analysis for pharmaceutical and biologic products
• •Familiarity with analytical testing procedures: AGE, qPCR/dPCR, HPLC (IEX, RP, SEC), Sequencing, Plate Based Assays (BCA, Kanamycin)
• •Strong knowledge of pharmacopeia (USP/EP) and regulatory requirements for the industry (ICH, GDP, cGMP and quality systems including OOS investigations, deviations and CAPAs)
• •Strong leadership and motivational capabilities
• •Ability to work well under pressure
• •Ability to handle multiple tasks/projects and meet deadlines
• •High attention to detail
• •highly organized
• •excellent documentation skills
• •Strong communication skills, both written and verbal in the English language
• •outstanding interpersonal skills
• •excellent documentation skills
• •Ability to be self-motivated, proactive, accountable, and flexible
• •Ability to work well under pressure
• •Ability to handle multiple tasks/projects and meet deadlines
• •Strong scientific, analytical, and problem-solving skills
• •sound judgment
• •Ability to provide support for regulatory and client audits
• •Ability to interact with clients
• •Ability to develop staff to improve individual and departmental performance
• •Ability to manage a team and work independently on projects
• •Ability to review project data and provide summary analysis reports based upon the data
• •Ability to exercise sound judgment within defined procedures and policies to determine appropriate action
• •Ability to identify problems and lead efforts to resolve them
• •Ability to set stretch goals and link them to strategic outcomes and business deliverables
• •Ability to provide open communication
• •Ability to exemplify effective teamwork skills
• •Ability to develop and maintain Quality QC systems
• •Ability to achieve organizational objectives through the coordinated achievements of subordinate staff
• •Ability to establish departmental goals and objectives and function with autonomy
• •Ability to manage the accountability and stewardship of human, financial, and often physical resources
• •Ability to ensure subordinate supervisors and professionals adhere to defined internal controls
• •Ability to manage systems and procedures to protect departmental assets
• •Ability to demonstrate experience in leadership
• •Ability to develop a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives
• •Experience in the development and establishment of operations of QC laboratories in a GMP regulated environment
• •In-depth experience related to method development, optimization, validation, and tech transfers
• •Ability to manage a team and work independently on projects
• •Ability to review project data and provide summary analysis reports based upon the data
• •Ability to provide support for regulatory and client audits
• •Ability to interact with clients
• •A profound understanding of analytical instrument principals and application of advance instrumentation analysis for pharmaceutical and biologic products
• •Familiarity with analytical testing procedures: AGE, qPCR/dPCR, HPLC (IEX, RP, SEC), Sequencing, Plate Based Assays (BCA, Kanamycin)
• •Strong knowledge of pharmacopeia (USP/EP) and regulatory requirements for the industry (ICH, GDP, cGMP and quality systems including OOS investigations, deviations and CAPAs)
• •Strong leadership and motivational capabilities
• •Ability to work well under pressure
• •Ability to handle multiple tasks/projects and meet deadlines
• •High attention to detail
• •highly organized
• •excellent documentation skills
• •Strong communication skills, both written and verbal in the English language
• •outstanding interpersonal skills
• •excellent documentation skills
• •Ability to be self-motivated, proactive, accountable, and flexible
• •Ability to work well under pressure
• •Ability to handle multiple tasks/projects and meet deadlines
• •Strong scientific, analytical, and problem-solving skills
• •sound judgment
• •Ability to provide support for regulatory and client audits
• •Ability to interact with clients
• •Ability to develop staff to improve individual and departmental performance
• •Ability to manage a team and work independently on projects
• •Ability to review project data and provide summary analysis reports based upon the data
• •Ability to exercise sound judgment within defined procedures and policies to determine appropriate action
• •Ability to identify problems and lead efforts to resolve them
• •Ability to set stretch goals and link them to strategic outcomes and business deliverables
• •Ability to provide open communication
• •Ability to exemplify effective teamwork skills
• •Ability to develop and maintain Quality QC systems
• •Ability to achieve organizational objectives through the coordinated achievements of subordinate staff
• •Ability to establish departmental goals and objectives and function with autonomy
• •Ability to manage the accountability and stewardship of human, financial, and often physical resources
• •Ability to ensure subordinate supervisors and professionals adhere to defined internal controls
• •Ability to manage systems and procedures to protect departmental assets
• •Ability to demonstrate experience in leadership
• •Ability to develop a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives
• •Experience in the development and establishment of operations of QC laboratories in a GMP regulated environment
• •In-depth experience related to method development, optimization, validation, and tech transfers
• •Ability to manage a team and work independently on projects
• •Ability to review project data and provide summary analysis reports based upon the data
• •Ability to provide support for regulatory and client audits
• •Ability to interact with clients
• •A profound understanding of analytical instrument principals and application of advance instrumentation analysis for pharmaceutical and biologic products
• •Familiarity with analytical testing procedures: AGE, qPCR/dPCR, HPLC (IEX, RP, SEC), Sequencing, Plate Based Assays (BCA, Kanamycin)
• •Strong knowledge of pharmacopeia (USP/EP) and regulatory requirements for the industry (ICH, GDP, cGMP and quality systems including OOS investigations, deviations and CAPAs)
• •Strong leadership and motivational capabilities
• •Ability to work well under pressure
• •Ability to handle multiple tasks/projects and meet deadlines
• •High attention to detail
• •highly organized
• •excellent documentation skills
• •Strong communication skills, both written and verbal in the English language
• •outstanding interpersonal skills
• •excellent documentation skills
• •Ability to be self-motivated, proactive, accountable, and flexible
• •Ability to work well under pressure
• •Ability to handle multiple tasks/projects and meet deadlines
• •Strong scientific, analytical, and problem-solving skills
• •sound judgment
• •Ability to provide support for regulatory and client audits
• •Ability to interact with clients
• •Ability to develop staff to improve individual and departmental performance
• •Ability to manage a team and work independently on projects
• •Ability to review project data and provide summary analysis reports based upon the data
• •Ability to exercise sound judgment within defined procedures and policies to determine appropriate action
• •Ability to identify problems and lead efforts to resolve them
• •Ability to set stretch goals and link them to strategic outcomes and business deliverables
• •Ability to provide open communication
• •Ability to exemplify effective teamwork skills
• •Ability to develop and maintain Quality QC systems
• •Ability to achieve organizational objectives through the coordinated achievements of subordinate staff
• •Ability to establish departmental goals and objectives and function with autonomy
• •Ability to manage the accountability and stewardship of human, financial, and often physical resources
• •Ability to ensure subordinate supervisors and professionals adhere to defined internal controls
• •Ability to manage systems and procedures to protect departmental assets
• •Ability to demonstrate experience in leadership
• •Ability to develop a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives
• •Experience in the development and establishment of operations of QC laboratories in a GMP regulated environment
• •In-depth experience related to method development, optimization, validation, and tech transfers
• •Ability to manage a team and work independently on projects
• •Ability to review project data and provide summary analysis reports based upon the data
• •Ability to provide support for regulatory and client audits
• •Ability to interact with clients
• •A profound understanding of analytical instrument principals and application of advance instrumentation analysis for pharmaceutical and biologic products
• •Familiarity with analytical testing procedures: AGE, qPCR/dPCR, HPLC (IEX, RP, SEC), Sequencing, Plate Based Assays (BCA, Kanamycin)
• •Strong knowledge of pharmacopeia (USP/EP) and regulatory requirements for the industry (ICH, GDP, cGMP and quality systems including OOS investigations, deviations and CAPAs)
• •Strong leadership and motivational capabilities
• •Ability to work well under pressure
• •Ability to handle multiple tasks/projects and meet deadlines
• •High attention to detail
• •highly organized
• •excellent documentation skills
• •Strong communication skills, both written and verbal in the English language
• •outstanding interpersonal skills
• •excellent documentation skills
• •Ability to be self-motivated, proactive, accountable, and flexible
• •Ability to work well under pressure
• •Ability to handle multiple tasks/projects and meet deadlines
• •Strong scientific, analytical, and problem-solving skills
• •sound judgment
• •Ability to provide support for regulatory and client audits
• •Ability to interact with clients
• •Ability to develop staff to improve individual and departmental performance