Sr. Director, Quality Assurance - Contract Manufacturing GMP

Paragon Bioservices is a growing biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a valued employee, you will actively contribute to the delivery of our services and products to our customers and their patients.

The Sr. Director, Quality Assurance provides strategic oversight and leadership to QA Operations and QA Client liaisons to ensure project objectives are met to a high-quality standard and according to commitments while ensuring current Good Manufacturing Practices (cGMPs) compliance for manufacturing of biological product, and compliance to US and EU regulations, as applicable.

Key responsibilities include but are not limited to:

• Develop compliant operational strategies by establishing critical metrics and measurements; conducting trend analysis; system design and implementation.
• Assure GxP operations are executed in compliance with applicable guidelines and regulations through quality risk management,
• Outlines department objectives, identifying continuous and compliance improvement initiatives, monitors progress of deliverables, and provides support to Managers and Associates
• Accountable for the batch record review and lot disposition activities to ensure release of lots within compliance with applicable regulatory submissions and prescribed timelines.
• Facilitates QA support and works closely with other Paragon functional units including Manufacturing, Validation, Facilities Engineering, Pre-Clinical and Quality Control to assess and resolve quality issues with regards to the facility and products manufactured
• Develop, sustain and implement procedures, programs and policies that support GMP operations and overall compliance strategy
• Serve as team leader in critical quality investigations and ensure corrective and/or preventive action plans to resolve potential product quality and compliance issues are appropriately implemented
• Participates in the Quality Metric review process, assess data for adverse trends, develop solutions and oversee implementation in their respective area
• Responsible for mentorship and supervision of designated staff to ensure effective execution of roles and responsibilities
• Responsible for staffing plans and overseeing training, professional development of employees and conducting performance reviews within group
• Work with senior management to initiate new client proposals and projects. This includes analyzing client proposals for resource allocation and QA costs generated by Business Development.
• Serve as site liaison for external client or regulatory audits, coordinating audit support, performing facility tours, answering questions and resolving issues. Respond to observations to ensure compliance risks are effectively mitigated
• Strategy reviewer of quality system documents including but not limited to CAPA, change controls, investigations, and deviations.
• Client Quality agreement construction, negotiation, and approval.Oversees QA Client liaison for hosting routine client audits. This includes coordinating audit support, performing facility tours, answering questions and resolving issues. Respond to observations to ensure compliance risks are effectively mitigated

Experience & Education:

• B.S. in a Life Sciences discipline- OR - M.S. in a Life Sciences discipline
• 12 years of experience within a GMP Manufacturing environment with the majority of experience in Quality Assurance Operations
• Prior experience in a CMO/CDMO environment required
• 8+ years of direct management experience required
• Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications Knowledge of quality business practices and business development.
• Proficiency with electronic management systems (such as QDMS, LMS, EDMS, and E-Doc)
• Advanced skills with MS Office applications and Adobe Acrobat

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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