About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job DescriptionPrimarily responsible for supporting AbbVie’s pipeline, by ensuring high-quality clinical supplies that are compliant with global regulatory requirements and standards are delivered to patients. The Senior Manager, Clinical Product Supply is primarily responsible for providing direction and quality oversight of the supply chain, including manufacturing, testing and release processes from drug substance to drug product to finished product. As a team member in interdisciplinary product development teams (e.g., CMC teams), the Senior Manager is responsible for early identification and prevention of pipeline risks by driving consensus-building across AbbVie R&D functions and external partners.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
- Provide program oversight for the RDQA QA organization; includes timely communications on program strategies and issue management.
- QA representative for CMC product development teams to facilitate the approval of drug to clinical trials according to program timelines
- Lead complex global cross-functional process improvement teams.
- Provide innovative and risk-based solutions to complex technical problems.
- Support the preparation of regulatory inspections and internal audits, and represent Quality in inspections and audits.
- Write/ review/ approve exception reports, including high impact and complex ERs impacting multi-functional areas.
- Provide management of clinical supply product actions and recalls.
- Support in-licensing and collaboration activities.
- Ensure suitable quality agreements or quality aspects of contracts are in place between R&D and third-party manufacturers, third party laboratories, and other service providers and other sites.
- Interact and influence decisions of the various R&D Directors and VP as well as external customers and mentor staff.
- Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
- Master’s degree is preferred but is not required based on commensurate experience.
- 8+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree.
- Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is required. Experience applicable to investigational products is preferred.
- Experience in project management and ability to manage multiple priorities. Project Management Professional (PMP) certification is preferred, but not required.
- Strong leadership, communication, and organizational skills.
- Must be able to provide and defend the quality position, and effectively problem solve complex technical and quality issues.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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
Skills Required
- Bachelor's degree in life sciences (biology, chemistry, engineering) or equivalent experience
- Master's degree
- 8+ years industry experience in Quality Assurance, production, testing of APIs, drug products, or drug development
- Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and global GMP (US, EU, D)
- Experience applicable to investigational products
- Experience in project management and ability to manage multiple priorities
- Project Management Professional (PMP) certification
- Experience preparing for regulatory inspections and representing Quality during inspections and audits
- Ability to write, review, and approve exception reports including high-impact and complex ERs
- Experience managing clinical supply product actions and recalls
- Experience establishing and ensuring quality agreements with third-party manufacturers and laboratories
- Strong leadership, communication, and organizational skills
- Ability to provide and defend quality positions and effectively problem-solve complex technical and quality issues
AbbVie Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.
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Retirement Support — 401(k) contributions include a dollar-for-dollar match up to 6% plus an additional annual company contribution tied to age and service. Company-paid life insurance and other financial protections further strengthen long-term security.
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Parental & Family Support — Paid leave programs include up to 12 weeks at 100% for parental leave and separate paid caregiver leave, with eligibility after six months where noted. Adoption and surrogacy reimbursements and family-building resources add further support.
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Healthcare Strength — Health coverage begins on day one with medical, dental, vision, mental health, and prescription benefits, and preventive care covered at 100%. Options such as HSAs/FSAs and coverage for spouses/domestic partners and children up to age 26 broaden accessibility.
AbbVie Insights
What We Do
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.
