AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Sr. Manager, QA
Primarily responsible for ensuring the successful and timely release of GMP clinical supplies by providing direction and oversight of the overall manufacturing, testing and release processes of cell and gene therapy products, including critical raw material, in-process material, drug substance to drug product to finished product.
- Serve as the QA point of contact in CMC and Supply Chain meetings and direct QA functional areas to facilitate the approval of therapeutics product to clinical trials to meet project timelines
- Support in-licensing, out-sourcing, and external collaboration activities
- Support the preparation of regulatory inspections and internal audits, and represents GMP Quality in inspections and audits.
- Ensure establishment of material and product specifications including QC analytics and risk identifications.
- Interact and influence decisions of the various R&D Directors and Vice Presidents as well as external customers and mentor Quality Engineers
- Serve as a subject matter expert and provide consultation & training on QA specific items to internal and cross-functional groups
- Lead complex global cross-functional process improvement along with SME.
- Work on unusually complex technical problems and provide solutions that are highly innovative and ingenious; resolve project team issues with minimal oversight
- Review and approve manufacturing batch records, analytical data/reports, and other GMP batch documents. Conduct batch release of cell and gene therapy products.
- Participate and manage investigations and support OOS, deviations, CAPA and Change Management/Change Controls.
- Ensure suitable quality agreements or quality aspects of contracts are in place between R&D and third-party manufacturers, third party laboratories, other service providers and other sites
- Provide management of clinical supply product actions and recalls
- Bachelor's degree or equivalent experience is required, typically in life sciences, engineering
- Minimum 6+ years of biopharma industry experience in Quality Assurance, drug development or other healthcare related field; less experienced considered with advanced degree (such as in Molecular or Cell Biology, Genetics, or Biochemistry, etc)
- Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents.
- Prior working experience in a GMP environment and/or with CDMO(s) is preferred.
- Broad understanding of pharmaceutical manufacturing processes including manufacturing process for viral and non-viral based gene therapy products, their release assays, analytical sciences, and worldwide quality requirements for GMP is required.
- Knowledge of regulatory compliance requirements should include historical perspectives and current trends of the regulatory agencies, especially for cell and gene therapies as they apply to the clinical manufacturing processes.
- Good communications skills
- Must have leadership skills and have been seen to take a position on quality issues and standards, and must be capable of clearly and logically justifying such positions.
- Other competencies are required, e.g., making difficult decisions, relationship-building, influencing, fostering teamwork, knowledge of the business and sound judgment
Applicable to California Applicants Only
The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California. This range may be modified in the future.
The salary range for this role is posted below
This job is eligible to participate in our short-term incentive program
This job is eligible to participate in our long-term incentive programs
We offer comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
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 discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: Yes, 10 % of the Time
Job Type: Experienced
Minimum Salary $110,500
Maximum Salary $216,000
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