Manufacturing Compliance Operations Manager
6 days ago
Alkermes is a global biopharmaceutical company that applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders.
We are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Our portfolio of proprietary commercial products addresses various conditions, including alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder. We also have a pipeline of clinical and preclinical candidates in development for various neurological disorders, such as narcolepsy.
Job DescriptionThe position of Manufacturing Compliance Specialist will play a vital role in supporting the ongoing commercial manufacturing effort in Wilmington. The individual will be responsible for establishing and maintaining GMP-compliant manufacturing systems, working closely with production personnel to ensure documents and production records comply with GMP regulations.
This role requires strong knowledge of pharmaceutical manufacturing processes, Good Manufacturing Practices (US and EU), and excellent communication skills. The successful candidate will be able to quickly understand detailed and complex processes, work efficiently, and effectively collaborate with internal and external stakeholders.
Key Responsibilities:
- Identify and resolve GMP non-compliance issues in the Manufacturing group
- Develop or revise SOPs and other GMP documentation supporting new or changed manufacturing processes
- Coordinate the approval process for GMP documentation between Manufacturing, QA, QC, and Development
- Review completed GMP documentation to ensure it is complete and accurate in preparation for product release
- Establish an ongoing program of continuous improvement related to quality, compliance, and system efficiency
- Assure the resolution of deviation corrective actions, action items from Change Control systems, and any audit non-compliance items
- Conduct informal audits as requested by Management in support of investigations and process failures
- Participate in audits by internal as well as external groups and agencies
- Provide support in document preparation related to regulatory filings, validations, and new product introduction
Requirements:
- Ability to work on and coordinate multiple projects in an orderly and efficient manner, consistently meeting established deadlines
- Ability to work cross-functionally to meet company objectives
- Strong knowledge of pharmaceutical manufacturing processes
- Working knowledge of Good Manufacturing Practices (US and EU)
- Strong oral and written communication skills
- Ability to quickly understand detailed and complex processes
- Team player committed to quality and working effectively with others, both internal and external to Alkermes
- Motivated self-starter
- Detail and results-oriented
- Dependable, well-organized
- Efficient with strong communication skills
Estimated Salary: $65,000 - $85,000 per year, depending on experience and qualifications.
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