Sr. QA Manager

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.

The Senior QA Manager will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. The role supports and provides quality oversight of the day-to-day operations of the Madison, WI based drug manufacturing facility. In this role, the opportunity exists for the incumbent to shape and transform GxP programs by providing QA expertise and guidance to lead product candidates and pipeline assets. The incumbent will also be a key member of a cross functional team focused on harmonization and improvement of quality systems and processes across all PCI WI GMP locations.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Provides quality oversight of manufacturing activities on a day-to-day basis.
• Review, develop, and improve quality system procedures, specifications, and test methods.
• Provide status reports, including relevant quality metrics and participates in the management review process.
• 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.
• Monitor, identify, and propose quality process/system improvements and provides strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement.
• Serve as QA representative to cross functional project teams such as process improvement.
• Perform risk assessments to comply with internal procedures and external guidelines.
• Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable.
• Ensures site readiness for regulatory inspections, client audits, and internal audits.
• Perform review of raw material documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization.
• Assist with internal audits, client audits as well as supplier audits as needed. Review and approve supplier documents requiring Quality approval.
• Interface with internal and external customers to address any documentation and compliance concerns.
• Provides oversight to Quality walkthroughs for Shutdown and Inspection Readiness activities and ensures compliance with site and corporate procedures.
• Establish and communicate performance objectives for Quality Assurance staff that are consistent with the business's unit goals, Quality and Technical Operations objectives. Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments.
• May provide Quality review and approval of investigations, deviations, events, change controls and CAPAs.
• Hires, integrates, and develops high quality talent, capable of delivering against the department's goals and objectives.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND PROFESSIONAL EXPERIENCE

• Knowledge of science generally attained through studies resulting in a BS degree in Science, Engineering, Biochemistry or related discipline, or its equivalent is required. ASQ certification preferred. ASQ certification preferred.
• Minimum of 8 years of pharmaceutical or biotech industry experience with 2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production. Minimum of 2 years of management responsibility preferred.
• A minimum of 8 years of overall experience in biopharmaceutical quality
• Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition and batch record review is highly desirable.
• Experience performing RCA, technical writing, and working with quality related investigations.
• Knowledge of laboratory and production equipment and IQ/OQ/PQ
• Knowledge of US and EU cGMP regulations and guidance
• Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9.
• Background and demonstrated effectiveness in quality assurance operations and compliance of commercial biologics manufacturing with oversight of final product release.
• Knowledge in Operational Excellence and Continuous Improvement is highly desirable.
• Experience in building and growing an organization into a high-performance team.
• Knowledge of electronic systems including any of the following Master Control, or electronic batch recording systems, is desirable. Microsoft Office suite knowledge and proficiency with Excel is desirable.

PERSONAL SKILLS & COMPETENCIES

• Exceptional organizational skills
• Ability to make risk-based decisions and resolve issues with minimal guidance.
• Excellent interpersonal skills and the ability to communicate well orally and in writing.
• Proficiency in MS Office including Word, Excel, Access, and Visio
• Ability to lead people in a dynamic, fast-paced work environment.
• Honesty, integrity, respect, and courtesy with all colleagues
• Creative with the ability to work with minimal supervision and balanced with independent thinking.
• Resilient through operational and organizational change
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Well-practiced in exercising sound judgment in decision-making
• Demonstrated multitasking and organization skills.
• Past experience where one was required to work in a team-based environment with a diverse group of people. Previous work responsibility, which required a high degree of attention to detail.

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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.