Senior Manager, Product Development Quality Assurance (CMC Product Lead) - Hybrid
Senior Manager, Product Development Quality Assurance (CMC Product Lead) - Hybrid
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Primarily responsible for ensuring the timely release of GMP clinical supplies by 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:
- QA representative for CMC product development teams to facilitate the approval of drug to clinical trials according to program timelines.
- Provide program oversight for the RDQA QA organization; includes timely communications on program strategies issue and risk management.
- 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 investigations impacting multi-functional areas.
- Provide management of clinical supply product actions and stock recovery.
- Conduct the onboarding of new assets.
- Perform due diligence of potential assets.
- 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.
- Interact with and influence decision making at the senior leadership level as well as with external customers.
Qualifications :
Bachelors in life sciences (biology chemistry or engineering) and/or equivalent experience.
Masters degree is preferred but is not required based on commensurate experience.
Minimum 8 years of 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.
A broad understanding of pharmaceutical manufacturing processes (chemical and biological) and analytical sciences.
Strong knowledge of global GMP requirements (EU US etc.) and international pharmaceutical law.
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 solve complex technical and quality issues.
Must have a team-oriented work style and strong collaboration skills.
Additional Information :
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 posting based 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 or less 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.
This job is eligible to participate in our long-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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
