Job summary
Job post source
This job is directly from Alkermes
Job overview
The Product Quality Lead at Alkermes provides onsite Quality Assurance support for Phase I/II oral dosage manufacturing and analytical activities, ensuring compliance with regulatory requirements and internal quality standards.
Responsibilities and impact
The role involves QA review and approval of GMP documentation, establishing GMP operational activities, liaising with various departments to resolve discrepancies, supporting batch disposition, monitoring KPIs, supporting regulatory filings, audits, and complaint handling.
Experience and skills
Requires a BSc in a scientific discipline and at least 10 years of pharmaceutical industry experience, preferably in Oral Solid Dose, with strong knowledge of FDA and EU cGMPs, quality management systems, risk assessment, and excellent communication and problem-solving skills.
Work environment and culture
The position emphasizes teamwork, quality commitment, flexibility, innovation, and the ability to work in a fast-paced environment with multiple simultaneous issues, supporting a hybrid work model.
Company information
Alkermes is a pharmaceutical company focused on drug development and manufacturing, committed to equal employment opportunity and compliance with regulatory standards.
Job location and travel
The job is hybrid with up to 15% travel within the USA and requires GMP gowning and occasional use of PAPR.
Unique job features
The role includes unique responsibilities such as supporting Phase I/II oral dosage manufacturing onsite, involvement in regulatory filings, and operational training programs.
Company overview
Alkermes is a global biopharmaceutical company that specializes in developing innovative medicines for central nervous system (CNS) diseases and oncology. They generate revenue through the research, development, and commercialization of pharmaceutical products, including proprietary drugs and collaborations with other pharmaceutical companies. Founded in 1987, Alkermes has a rich history of scientific innovation and has developed several FDA-approved therapies. The company is headquartered in Dublin, Ireland, with a significant operational presence in the United States.
How to land this job
Tailor your resume to emphasize your extensive knowledge of FDA and EU cGMP regulations, especially related to Phase I/II oral dosage manufacturing and analytical activities, highlighting your ability to ensure compliance and quality standards.
Showcase your experience with Quality Management Systems like Veeva, Trackwise Digital, Valgenesis, and SAP, as well as your skills in risk assessment, deviation management, and batch disposition processes.
Apply through multiple platforms including Alkermes' corporate careers page and LinkedIn to maximize your application visibility and ensure your resume reaches the right hiring managers.
Connect on LinkedIn with current Alkermes Quality Assurance professionals or those in manufacturing and regulatory divisions; use ice breakers such as commenting on recent Alkermes quality initiatives or asking about their experience managing GMP compliance in oral solid dose manufacturing.
Optimize your resume for ATS by incorporating keywords from the job description such as 'GMP documentation review,' 'analytical method qualifications,' 'cleaning verification,' 'environmental monitoring,' 'batch disposition,' and 'cGMP audits' to pass automated screenings.
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