Job Description
This role is primarily associated with responsibility for analytical QA oversight for both
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clinical and
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commercial Alkermes proprietary products. This includes direct QA oversight of testing (specifications, method validations, release and stability) for API and Drug Product manufactured externally to Alkermes, as well as oversight of all contract test organizations for all Alkermes proprietary clinical and commercial products
Responsibilities
* Responsible for ensuring Alkermes development programmes are following ICH/EU/FDA and associated guidance's.
* Responsible for ensuring consistency to management of contract test organizations ensuring compliance with the regulatory requirements and company standards for analytical related aspects.
* Ensure compliance of quality systems, other applicable regulations/standards and internal procedures.
* Support implementing improvements at the CDMO/CMO/CTO's in deviation and change control systems.
* Review and approval of deviations, SOP's and change controls
* Liaise with Analytical Development, Process Development, Alkermes QPs, other QA teams, to resolve any discrepancies noted during analytical and batch record review.
* Provide the requisite quality support to the regulatory/CMC group in support of regulatory filings.
* QA lead for root cause analysis and risk assessment activities
* Provide support for complaints as applicable.
(*Note: Commercially, as it relates to external activity and internally as it relates to clinical and commercial analytical oversight. These specific items may be performed by site-based roles in DEQA).
Qualifications
Minimum Education & Experience Requirements:
* BSc in scientific discipline or equivalent.
* 6+ years' experience in the pharmaceutical industry, preferably in Oral Solid Dose with strong background in associated Analytical testing
* Experience in Analytical methods in small molecule
Knowledge/Skills Needed
* Strong communication skills and an ability to influence key stakeholders
* Excellent verbal and written skills
* Excellent interpersonal skills
* Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing and analytical requirements
* Experience in pharmaceutical product development
* Strong ability to troubleshoot and problem solve
* Demonstrated proficiency in use of risk assessment tools
* Experienced in use of Quality Management Systems such as Veeva, Trackwise Digital, Valgenesis and SAP.
* Demonstrated ability to prioritize work to act and work independently
* The position will require up to 20% percent travel
* Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks
* Can get things done on the basis of influence
* Comfortable working in a fast-paced environment with multiple issues open simultaneously
* Identifies opportunities to improve and contributes to problem solving