Director, Third Party Manufacturing
AbbVie
July 02, 2026
Remote friendly (North Chicago, IL)
United States
Operations
Director, Third Party Manufacturing (all genders)
Your tasks and responsibilities:
- Lead end-to-end management of third-party manufacturing activities for assigned products, sites, and external partners to ensure supply continuity and GMP operational excellence within R&D.
- Oversee initiation, review, and approval of external manufacturing documentation and agreements (CDAs, RFPs, MSAs, technical quality agreements).
- Coordinate with TPMs, AbbVie Operations, QA, R&D, Legal, Procurement, Business Operations, Analytical, VLOG, and others on manufacturing instructions, batch records, sample coordination, and shipment execution.
- Act as key contact for issues, escalations, deviations, and investigations; ensure timely resolution and quality outcomes.
- Support tech transfer and post-transfer manufacturing readiness for clinical and commercial supply.
- Ensure manufacturing processes/documentation meet AbbVie and external regulatory expectations (batch records, release processes, quality documentation).
- Lead/participate in audits, site visits, and technical assessments.
- Drive process improvements and standardization across third-party manufacturing and related supply chain processes.
- Monitor partner performance and manage relationships.
- Develop, coach, and hold team members accountable.
Qualifications:
- Bachelor’s degree in scientific/engineering/related field required; advanced degree preferred.
- Extensive experience in pharmaceutical/biopharmaceutical manufacturing, third-party manufacturing, quality, technical operations, or supply chain support.
- Demonstrated experience managing external manufacturing partners/CMOs/TPMs.
- Strong GMP knowledge, quality systems, batch record documentation, and technical quality agreements.
- Experience with tech transfer and manufacturing readiness.
- Leadership and cross-functional collaboration skills.
- Strong problem-solving, decision-making, escalation management.
- Ability to manage multiple priorities and complex projects.
Application instructions:
- Submit a complete CV; AbbVie will discuss the rest in person.
Your tasks and responsibilities:
- Lead end-to-end management of third-party manufacturing activities for assigned products, sites, and external partners to ensure supply continuity and GMP operational excellence within R&D.
- Oversee initiation, review, and approval of external manufacturing documentation and agreements (CDAs, RFPs, MSAs, technical quality agreements).
- Coordinate with TPMs, AbbVie Operations, QA, R&D, Legal, Procurement, Business Operations, Analytical, VLOG, and others on manufacturing instructions, batch records, sample coordination, and shipment execution.
- Act as key contact for issues, escalations, deviations, and investigations; ensure timely resolution and quality outcomes.
- Support tech transfer and post-transfer manufacturing readiness for clinical and commercial supply.
- Ensure manufacturing processes/documentation meet AbbVie and external regulatory expectations (batch records, release processes, quality documentation).
- Lead/participate in audits, site visits, and technical assessments.
- Drive process improvements and standardization across third-party manufacturing and related supply chain processes.
- Monitor partner performance and manage relationships.
- Develop, coach, and hold team members accountable.
Qualifications:
- Bachelor’s degree in scientific/engineering/related field required; advanced degree preferred.
- Extensive experience in pharmaceutical/biopharmaceutical manufacturing, third-party manufacturing, quality, technical operations, or supply chain support.
- Demonstrated experience managing external manufacturing partners/CMOs/TPMs.
- Strong GMP knowledge, quality systems, batch record documentation, and technical quality agreements.
- Experience with tech transfer and manufacturing readiness.
- Leadership and cross-functional collaboration skills.
- Strong problem-solving, decision-making, escalation management.
- Ability to manage multiple priorities and complex projects.
Application instructions:
- Submit a complete CV; AbbVie will discuss the rest in person.