Sr Mgr/TL API Release Operations
$139,100–$231,900 year
On-siteKalamazoo, Michigan, United States
Job Summary
Manage oversight of lot release, production deviation review, lab investigation review, batch record review teams, QO tech transfer, and supplier quality. Set objectives for high-complexity projects within the API Quality Assurance Business Unit and lead people, technological, and financial resources. Review and approve compliance documents including regulatory submissions, deviations, validation reports, stability reports, internal audits, Annual Product Reviews, and SOPs. Lead identification of continuous process improvements to enhance operations while evaluating GMP/GDP compliance. Support regulatory and customer audits, potentially serving as the audit host during on-site inspections. Implement corrective and preventive actions for quality issues and lead cross-functional projects with Medical and Pfizer counterparts. Oversee training needs for colleagues and alliance partners regarding procedures, policies, and systems.
Required Qualifications
- Bachelor's degree
- Master's degree
- PhD
- At least 6 years of experience (with Bachelor's degree)
- At least 5 years of experience (with Master's degree)
- At least 1+ years of experience (with PhD)
- Experience in GMP-regulated industries in Manufacturing Operations
- Process Validation with Quality Systems knowledge
- Demonstrated record of successful interaction with global regulatory and other internal and external auditing groups
- Thorough understanding of the technical and commercial aspects of pharmaceutical API / Drug products
- Excellent verbal and written communication skills
- The ability to influence and collaborate with peers
- The ability to develop and coach others
- The ability to oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
- Permanent work authorization in the United States
Desired Qualifications
- Solid understanding of training design and tools and experience in applying effective training methodologies
- Experience in managing cross-functional teams
- Strong analytical and problem-solving skills
- Ability to work in a fast-paced, dynamic environment
- Excellent organizational and project management skills
- Strong leadership and team-building skills
- Experience in developing and implementing strategic initiatives
- Experience using common AI tools, including generative technologies such as ChatGPT, Microsoft Copilot, Claude, or Open AI to support problem solving
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