Associate Director, External Quality

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

We are seeking a growth and improvement minded External Quality Associate Director that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Opportunities and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Key Responsibilities

• Provides Quality oversight over one or more External Entities or projects that will manufacture or tests cell banks, biologic drug intermediates, biologic drug substances, or biologic drug products or both on behalf of our Company for product and analytical technology transfer.

• Serve as the quality project lead for Technology Transfer, New Product Introduction and Analytical Transfers to Contract Manufacturing and testing sites.

• Assist in managing the end-to-end processes of transfers including but not limited to: Due Diligence, Feasibility Studies, Protocols/Reports, PPQ, PAI Readiness and Quality System Oversight Implementation.

• Works with a team of quality project leads and cross functional transfer teams.

• Reports to the Quality Director, EQA, for general advice and instruction concerning Quality Operations, but functions independently

Education

• Bachelor's or Master's degree in a Science, Engineering, or related area of study.

Required

• Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect

• Seven years or greater relevant pharmaceutical or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control

• Solid knowledge of global GMP and regulatory requirements

• Proficient in analyzing complex product, production and testing issues and have demonstrated scientific problem solving capabilities

• Experience with supporting regulatory inspections

• Principled and strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships

Preferred

• Biologic and/or vaccine Quality Assurance and Quality Control

• Contract Manufacturing Oversight (CMOs, Labs, etc.)

• Experience with working in regulated environment and with new product introductions / product transfers.

• IPI, QSAT and SAP for deviation and CAPA management experience preferred.

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. 

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but h