Quality Assurance Supervisor

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

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.

Job Details:
We are currently seeking a Quality Assurance Supervisor that provides Quality Assurance (QA) oversight for a wide variety of highly complex GXP activities to assure compliance with U.S. and international regulatory requirements, including development, implementation, maintenance, and performance of QA systems and programs. This position is responsible for both routine and semi-routine activities that includes QA operational support oversight, quality event investigation support, document creation and review, Quality Management System (QMS) inputs, and batch release.

Responsibilities:

• Continually assesses the efficiency and effectiveness of executed technical documentation in support of the manufacture and testing of Drug Substance and Drug product.
• Oversees routinely scheduled functions to support CGMP processes.
• Champions CGMP activities by with oversight, guidance, and quality decision making.
• Appropriately leads and coaches direct reports in confident, quality decision-making and builds depth of knowledge within assigned QA team(s).
• Establishes and communicates KPIs to senior management.
• Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis. May be required to communicate to client partners.
• Provides training opportunities for direct reports.
• Performs reviews of production records and associated data to ensure compliance. May be responsible for batch approval/rejection.
• QA collaboration and review for quality investigations (deviations, OOS, CAPAs, etc). Provide client facing quality support for unplanned events. Implement solutions and corrective actions that align with regulations and internal processes.
• Review, revise, create and approve Quality SOPs.
• Provide clear, accurate client related communications and attend client-facing meetings as needed.
• Regular and reliable attendance on a full time basis, hybrid flexibility allowed.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies PCI’s cultural values and aligns daily actions with department goals and company culture.

Requirements:

• Bachelor’s degree in Life Sciences discipline or equivalent is required.
• Minimum of 3 years of experience in Quality with-in a regulated life sciences industry with a degree or 5 years of equivalent experience without a degree.
• Minimum of 1 - 3 years of functional leadership/supervisory experience in the life sciences industry.
• Working knowledge of drug development and GMP aseptic processing operations.
• Knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices.
• Strong knowledge of GXP regulations and good documentation practices.
• Detail oriented and strong written and verbal communication skills.

The base hourly range for this position is $76,000 – $85,500 USD plus annual performance bonus eligibility. Final offer amounts are determined by multiple factors including and not limited to specific and relevant experience, credentials, geography and subject matter expertise.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.