Director, Quality Systems & Compliance

Job Description

Our Quality Assurance Group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our 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.

Summary, Focus and Purpose

The Director of GMP Compliance will report to the head of the Global Quality Compliance Support organization.  The responsibility of this position crosses all Human & Animal Health operating units and requires extensive partnership with manufacturing sites and global GMP SMEs.

Key Functions

• Serve as a subject matter expert for good manufacturing practices for drug products, active pharmaceutical ingredients, biologics, vaccines, and devices
• Ensure that global QMS documents meet major health authority GMP requirements 
• Provide consulting and research services to global QMS topic owners and site quality experts to assess the compliance impact of potential updates to our company’s policies and procedures
• Oversee a program to prevent repeat health authority observations throughout the Manufacturing Division network and to share knowledge of relevant findings with key stakeholders
• Serve as the global topic owner for regulatory inspections, audit & inspection CAPAs, and network observation sharing
• Maintain an internal library of GMP-relevant information and make use of external databases for consultative services
• Provide GMP compliance guidance and assistance before, during, and after major health authority inspections
• Maintain a network of external peers in the regulated industry through appropriate forums (e.g., PDA, PQRI, PhRMA, ISPE, etc.) guide regulatory benchmarking activities

Education Minimum Requirement and Experience

• Bachelor’s Degree (B.S.) with a preference in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required with ten (10) years of quality, operational, or technical experience within the GMP regulated environment, OR
• Master’s Degree (M.S.) with a preference in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required with eight (8) years of quality, operational, or technical experience within the GMP regulated environment, OR
• PhD with a preference in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required with five (5) years of quality, operational, or technical experience within the GMP regulated environment

Required Knowledge and Skills

• Expert knowledge of GMPs and regulatory requirements and expectations.
• Experience and exposure (not less than 5 years) in managing health authority inspections and communications in a pharmaceutical or biotechnology manufacturing site.  
• Strong background in data analytics
• Demonstrated ability to creatively use multiple methods of analysis to decipher large datasets, including text-based and unstructured datasets
• Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.
• Accountable for actions, drives results, and learns from mistakes
• Demonstrates good judgment and logical thought processes in collecting and synthesizing relevant data and information to make independent and timely decisions
• Communicates, influences, and escalates issues and decisions, as appropriate
• Communicates effectively up and down, at all levels of the organization
• Demonstrates tolerance for ambiguity
• Able to travel up to 20% of the time

Preferred Experience and Skills

• A minimum of 15 years of quality, operational, or technical experience within the GMP regulated environment
• Experience working for a health authority/board of health as an inspector, product reviewer, compliance officer, or other GMP/regulatory role
• Strong background and technical understanding of vaccines and/or biologics
• Expert knowledge of international GMPs/requirements of multiple regulatory agencies

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