Director, Quality Contamination Control / Sterility Assurance

Job Description The Director, Quality Contamination Control / Sterility Assurance is responsible for the implementation of a strong quality culture across all the AbbVie operations with a focus on aseptic and low bioburden manufacturing. The role will provide microbial contamination control oversight for AbbVie’s sterile and low bioburden sites to assure sterility. Serves as a leading Subject Matter Expert (SME) for contamination control and sterility assurance for AbbVie network and Third-Party Manufacturers (TPMs). Supports the Global Engineering programs and late-stage development programs by ensuring facility, equipment, products and processes meet required regulatory standard and expectation for sterility assurance.  Responsibilities: Leads and manages the strategy for sterility assurance across the global AbbVie network Provides technical and regulatory guidance to the AbbVie network and TPMs supporting microbial contamination control and sterility assurance Drives and fosters a robust microbial contamination control and sterility assurance quality culture with transparency and innovation Improves standardized procedures across the network for sterility assurance including aspects of facility and equipment design, process design, material transfer, maintenance, training, sampling, testing, and cleaning / disinfection Drives and oversees global microbial contamination control and sterility assurance strategy in close collaboration with Senior Director of Global Programs, Director Aseptic Manufacturing, Director Biologics Drug substance manufacturing, Site Heads and Site Quality Leads Oversees facility, equipment design, and contamination control assessments for global AbbVie network and TPMs  Partners with the AbbVie Auditing team as the SME for key TPM, CMO, and sterile suppliers Drives and oversees global microbial contamination control and sterility assurance strategy, risk assessment, mitigation definition and gap closure, as well as sustainable implementation in close collaboration with all sites and TPMs Advances the contamination control expertise across the network and TPMs.   Proactively mentors, advises, and shares industry best practices with team members, peers and senior management Serves as an SME for AbbVie sites and TPMs in audit readiness, investigations and strategy development. Qualifications Qualifications Bachelor’s or Master`s in Microbiology or other relevant field 12+ years of experience within aseptic / sterile manufacturing and Quality Assurance in the pharmaceutical industry Technical experience with Global Engineering programs supporting aseptic / sterile manufacturing and low bioburden manufacturing Technical knowledge of aseptic facility design, clean room engineering, including particle and microbial control mechanisms, qualification and maintenance of clean rooms Knowledge of biologics, pharmaceuticals, ADCs, new modalities, devices, combination and OTC products Proven hands-on experience in sterility assurance, contamination control and troubleshooting challenges Ability to apply microbiological control concepts and risk assessment in a practical way and to coach / teach team members in these areas Knowledge and experience in microbiological test technologies/methodologies Must be able to establish and maintain effective working relationships with stake holders in Manufacturing, Engineering and Quality and TPMs Ability to travel globally ~ 30% as required, and to utilize technology to stay connected across all major time zones Excellent working knowledge of cGMP and the regulatory requirements for manufacture of sterile and low Bioburden products (FDA, EMA, PIC/s) Previous experience as Qualified Person for sterile manufacturing site preferred Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit  https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html   US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html