Provide onsite Quality Assurance (QA) support for the establishment and operation of Phase I/II oral solid dosage (OSD) manufacturing and analytical activities, with primary focus on analytical lifecycle oversight (instrument qualification, method validation, stability, and data review), cleaning validation for manufacturing equipment, and QA support batch manufacturing. Ensure all activities are executed in full compliance with FDA/EU cGMP requirements and internal quality standards, and support batch disposition through robust data review and cross‑functional collaboration.

Responsibilities

QA oversight of analytical lifecycle activities:
- Review and approval of analytical instrument qualification and method validation documents
- Review and approval of stability protocols, reports and ongoing stability data review
- Ensure data integrity, completeness and compliance of analytical data supporting batch release
- Collaboration with Analytical Development to resolve discrepancies and provide QA support for lab investigation
- Provide QA oversight and ownership of the Cleaning Validation and Cleaning Verification program, including strategy, protocol development, execution, and reporting
- Lead and/or support execution of cleaning verification activities, including collection of rinse and swab samples, protocol authoring and report generation
- Ensure compliance with regulatory expectations for cross‑contamination control and product changeover
Establish and perform GMP operational activities in support of Phase I/II manufacturing:
- Sampling and disposition of incoming raw materials and finished products
- Sampling and monitoring of the USP Water System
- Development and oversight of the Environmental Monitoring Program
- Operational training programs, such as gowning, sampling, and GMP fundamentals
- Creation and maintenance of operational SOPs and programs as required
- Issuance of Control records
Manufacturing QA Oversight
- Provide QA support for GMP manufacturing, including line clearances and on‑floor QA oversight
- Ensure compliance with cGMP behaviors, SOPs, and batch records
Batch Disposition Support and Data review:
- Perform batch records, supporting documentation and analytical data packages
- Compile data required for QP disposition
- Support trending and KPIs for batch disposition performance
- Provide QA review and approval of other GMP documentation, such as:
  - Master and executed batch records
  - Quality risk assessments
  - SOPs and work instructions (related to all functional areas)
  - Raw material/API release documentation
  - Deviations, CAPAs and change controls
Provide support to the regulatory/CMC group in support of regulatory filings as required
Provide support for complaints as applicable
Support internal and external audits as required

Qualifications

Minimum Education & Experience Requirements:

BSc. in a 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, cleaning validation and Quality Assurance in support of pharmaceutical development operations
Ability to be the main point of contact and interact effectively in relation to on-site cGMP audits by external auditors

Knowledge/Skills Needed:

Strong communication skills and an ability to influence key stakeholders
Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing and analytical requirements
Strong understanding of data integrity and validation lifecycle principles
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
Experience working with Controlled Substance (a plus)
Ability to perform work in GMP gowning with occasional need to wear a PAPR
Excellent verbal and written skills
Excellent interpersonal skills
Position will require up to 15% travel within USA

Personal Attributes Needed

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

Compensation

The annual base salary for this position ranges from $128,000 to $142,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package.

Equal Employment Opportunity

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E‑Verify employer.

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