Director Site Quality Control *PC 1600
$192,952–$226,954 year
On-siteGaithersburg, Maryland, United States
Job Summary
Lead site-level Quality Control functions by developing and implementing GMP protocols for biological products, managing method implementation, transfer, validation, sampling plans, stability studies, and lot release testing. Drive strategic decisions on product quality and Quality Control systems while ensuring compliance with FDA, ISO, EMA, and ICH regulations. Manage a matrix leadership structure to foster employee development, promote cross-site exchanges, and embed a quality-first culture. Support manufacturing investigations, ensure stakeholder communication, and align site activities with global process streamlining and harmonization efforts within the Global QC Leadership Team.
Required Qualifications
- Bachelor's degree in Biologics, Chemistry, Biochemistry, Analytical Chemistry, or a related field
- 10+ years' industry experience in analytical development and/or quality (control) in a pharmaceutical/ Biotech industry within a GMP regulated environment
- experience in a leadership role
- Experience in product characterization
- analytical method validation
- transfer of analytical methods for testing biologics
- Extensive knowledge of cGMP regulations and guidelines
- strong knowledge of FDA, ISO, EMA, and ICH requirements applicable to biologics and cell therapies
- Demonstrated experience in leadership
- expertise in growing and developing teams
- experience in organizational change management
- Commitment to maintain data integrity
- strict adherence to standardized procedures
- relevant compliance requirements
- Excellent written and verbal communication skills
- Highly organized
- ability to dynamically re/prioritize efforts
- Adept change agent
- proactively soliciting input
- garner broad sustainable support
- Creatively navigates and converges business and compliance objectives
- Foster a culture of collaboration, open communication, and continual improvement
- Regularly required to walk
- use hands to finger, handle, or feel
- reach with hands and arms
- talk
- hear
- required to stand
- climb or balance
- stoop, kneel, crouch
- occasionally lift and/or move up to 20 pounds
- Specific vision abilities including close vision, color vision, peripheral vision, depth perception and ability to adjust focus
- ability to handle more than one task at a time
- work at a rapid pace
- maintaining attention to detail
- Must have ability to handle more than one task at a time
- Must work at a rapid pace while maintaining attention to detail
- Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves
Desired Qualifications
- preferred flow cytometry
- PCR methodologies
- HPLC
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