47 applicants

Company

Original Job Post

Alkermes · 3 days ago

Product Quality Lead

Greater Boston

Full-time

Onsite

Senior Level

10+ years exp

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BiotechnologyHealth Care

H1B Sponsorship

Comp. & Benefits

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Responsibilities

Onsite QA support for Phase I/II oral dosage drug product manufacturing and analytical activities, maintaining knowledge of industry standards and regulatory requirements to ensure compliance.

Review and approval of various documents including analytical instrument qualifications, batch production records, deviations, change controls, and more.

Liaise with different teams to resolve discrepancies and provide support for GMP manufacturing.

Identify continuous improvement opportunities, provide quality support for regulatory filings, and perform internal audits.

Qualification

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Pharmaceutical industry experienceBiologics drug substance processingDevelopment/CMO operationsHealth authorities interactionGMP knowledgeTechnical know-howCommunicationInfluenceNegotiationPrioritizationIndependenceInterpersonal

Required

BS in scientific discipline or equivalent

Minimum of 10 years’ broad experience in the pharmaceutical industry; preferably in Oral Solid Dose with strong background in associated Analytical testing, manufacturing and Quality Assurance in support of pharmaceutical development operations

Ability to be main point of contact and interact effectively in relation to on-site cGMP audits by external auditors

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

Experienced in use of Quality Management Systems such as Veeva, Trackwise Digital, Valgenesis, SAP

Demonstrated proficiency in use of risk assessment tools

Demonstrated strong negotiation skills

Demonstrated ability to prioritize work to act and work independently

Has a strong broad GMP and technical know-how to handle emerging issues

Excellent verbal and written skills

Excellent interpersonal skills

The position will require up to 20% percent travel within USA

Company

Alkermes

Glassdoor

3.9

Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.

Founded in 1987

Dublin, Dublin, IRL

1,001-5,000 employees

http://www.alkermes.com

H1B Sponsorship

Alkermes has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2020 (32)