QA Supervisor, External QA

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Position Title: QA Supervisor - External QA Operations

Location: Bedford, New Hampshire

Department: QA

Reporting To: QA Director

Responsible For (Staff): Yes

The QA Supervisor works with other departments to ensure the quality of products and compliance to internal procedures and external standards. The role supports and provides quality oversight for client facing QA operations, including Batch Record review and final product lot disposition. This position also includes the responsibility for evaluating events, deviation incidences and determining if each should be escalated to an investigation, Change Control assessments, quality review and approval of investigation, and creating and monitoring the associated CAPAs.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner
• Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable
• Responsible for quality oversight of manufacturing activities on a day to day basis and administration of the Quality investigation records and CAPA programs
• Review / approve Manufacturing, QC, and other investigations in support of batch release and cGMP compliance. Provide direction for complex investigations and CAPAs
• Ensure timely, accurate and complete execution and documentation of quality system events including deviations, GxP investigations and CAPAs
• Review and approve CAPAs and associated change control to prevent recurrence of deviations
• Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review process
• Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvement
• Perform risk assessments to comply with internal procedures and external guidelines
• Review, develop, and improve quality system procedures, specifications, and test methods.
• Monitor, identify and propose quality process and system improvements. Lead improvement projects and communicate status to management
• Manage assigned QA staff, providing feedback and development to enhance team capability. Provide training on department specific procedures and systems
• Partner with QA staff to ensure site readiness for regulatory inspections. Assist with internal audits and supplier audits as needed
• Interface with clients to address any documentation and compliance concerns

QUALIFICATIONS:

Required:

• Bachelor's Degree in a relevant scientific discipline preferred with a minimum of 5+ years of pharmaceutical or biotech industry experience
• Experience performing RCA, technical writing, and working with quality related investigations
• Knowledge of laboratory and production equipment and IQ/OQ/PQ
• Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH.

Preferred:

• Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
• Knowledge of electronic systems including any of the following SAP, LIMS, MasterControl, Trackwise, Veeva, or electronic batch recording systems, is desirable.
• Microsoft Office suite knowledge and proficiency with Excel is desirable.
• Previous Supervisory experience 'Preferred'
• ASQ certification preferred

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.