Director, Manufacturing QA
AbbVie
August 31, 2026
Remote friendly (Waco, TX)
United States
$160,500 - $305,000 USD yearly
Operations
Responsibilities
- Own overall quality for pharmaceuticals (small molecule/biologics), combination products, and medical devices; ensure compliance with delivery, company policies, and worldwide regulatory requirements.
- Lead end-to-end product quality for NPI supply chain and department budget; manage assigned product transfers.
- Serve as principal quality, global supply chain representative for external manufacturing; build relationships with TPM Operations, AbbVie plants/affiliates, Regulatory Affairs, R&D, Global Supply Chain, and S&T.
- Lead Product Quality Assurance transfer managers; align third-party manufacturers and internal sites on quality/compliance/resource needs.
- Ensure quality elements for new product launches, including third-party supplied products to distribution centers or AbbVie sites for further manufacturing/packaging/testing.
- Develop and implement global Product Quality Assurance strategy; provide QA input during development and resolve quality/compliance issues.
- Support legal supply agreements/contracts/LOIs with correct quality, compliance, and regulatory terms; approve quality/technical agreement actions.
- Act as decision maker on product quality/compliance/regulatory conformance; conduct management reviews with TPMs; plan readiness for audits/inspections; interface with regulators (e.g., FDA/EMA/MHRA/ANVISA).
- Lead quality liaison and negotiations with TPMs; oversee validations/qualifications and manage corrective actions.
Qualifications
- Bachelor’s degree in Life Science, Pharmacy, or Engineering (Graduate degree preferred).
- Technical/analytical background for problem resolution.
- 15+ years total experience; minimum 5 years manufacturing and 4 years QA/R&D and/or S&T; at least 6 years management/supervision.
- Minimum 5 years in a direct plant pharmaceutical setting; regulatory inspection experience with direct inspector interaction.
- Expert knowledge of biological/pharmaceutical technologies (sterile, biologics, liquids/solids, devices, etc.).
- Strong leadership; urgency, multitasking, data-driven problem solving; ability to work across cultural/language differences.
- Experience with requirements for third-party external manufacturing.
Benefits (if applicable)
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k).
- Eligible for long-term incentive programs.
- Own overall quality for pharmaceuticals (small molecule/biologics), combination products, and medical devices; ensure compliance with delivery, company policies, and worldwide regulatory requirements.
- Lead end-to-end product quality for NPI supply chain and department budget; manage assigned product transfers.
- Serve as principal quality, global supply chain representative for external manufacturing; build relationships with TPM Operations, AbbVie plants/affiliates, Regulatory Affairs, R&D, Global Supply Chain, and S&T.
- Lead Product Quality Assurance transfer managers; align third-party manufacturers and internal sites on quality/compliance/resource needs.
- Ensure quality elements for new product launches, including third-party supplied products to distribution centers or AbbVie sites for further manufacturing/packaging/testing.
- Develop and implement global Product Quality Assurance strategy; provide QA input during development and resolve quality/compliance issues.
- Support legal supply agreements/contracts/LOIs with correct quality, compliance, and regulatory terms; approve quality/technical agreement actions.
- Act as decision maker on product quality/compliance/regulatory conformance; conduct management reviews with TPMs; plan readiness for audits/inspections; interface with regulators (e.g., FDA/EMA/MHRA/ANVISA).
- Lead quality liaison and negotiations with TPMs; oversee validations/qualifications and manage corrective actions.
Qualifications
- Bachelor’s degree in Life Science, Pharmacy, or Engineering (Graduate degree preferred).
- Technical/analytical background for problem resolution.
- 15+ years total experience; minimum 5 years manufacturing and 4 years QA/R&D and/or S&T; at least 6 years management/supervision.
- Minimum 5 years in a direct plant pharmaceutical setting; regulatory inspection experience with direct inspector interaction.
- Expert knowledge of biological/pharmaceutical technologies (sterile, biologics, liquids/solids, devices, etc.).
- Strong leadership; urgency, multitasking, data-driven problem solving; ability to work across cultural/language differences.
- Experience with requirements for third-party external manufacturing.
Benefits (if applicable)
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k).
- Eligible for long-term incentive programs.