GMP Compliance Expert

Job Description

The Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality Compliance Support organization. The responsibility of this position crosses all Human & Animal Health operating units and requires extensive collaboration with manufacturing sites and global GMP SMEs.

Job Function:

• serve as a subject matter expert for good manufacturing practices (GMP) for drug products, active pharmaceutical ingredients, biologics, vaccines, and devices
• support remediation activities and pre-approval inspection readiness activities
• provide expert guidance and assistance to our company's manufacturing sites along with our contract manufacturing operations on GMP matters before, during, and after health authority inspections
• ensure CAPAs intended to address audit findings are effective and adequately implemented
• ensure new and developing global standards and procedures impacting manufacturing sites are fully compliant with international regulatory expectations
• serve as an SME for health authority reporting (e.g., FAR, BPDR, DPRs, MDRs)
• develop and use data analytics tools to assess compliance risk at sites
• support our company's audit program by identifying audit targets and help develop protocols for targeted assessments
• actively participate in industry organizations such as, PDA, PQRI, PhRMA, ISPE, etc.

Minimum Education Requirement and Experience:

• Bachelor of Science (B.S.) 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 of Science (M.S.) 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
• Ph.D. 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 Skills and Experience:

• Able to travel up to 50% of the time
• 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, biotechnology, or device manufacturing site
• Strong familiarity with sterile manufacturing operations and compliance requirements for aseptic processing
• Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.
• History of being accountable for actions and driving results
• Good judgment and logical thought processes in collecting and synthesizing relevant data and information to make independent and timely decisions
• Ability to communicate, influence, and escalate issues and decisions, as appropriate
• Expert knowledge of international GMPs/requirements of multiple regulatory agencies

Preferred Skills and Experience:

• 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, investigator, product reviewer, compliance officer, or other GMP/regulatory role
• Strong background in data analytics
• Demonstrated ability to creatively use multiple methods of analysis to decipher large datasets, including text-based datasets (e.g., lists of compliance observations)
• Strong background and technical understanding of vaccines and/or biologics