Job Description

POSITION SUMMARY:

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

ESSENTIAL AREAS OF RESPONSIBILITY:

QA support for onsite Phase I/II oral dosage drug product manufacturing and analytical activities, maintaining knowledge of industry standards and regulatory requirements to ensure all drug product manufacturing, testing, storage and shipping activities are compliant. These activities may include:

• Provide QA oversight of analytical lifecycle activities, including:
• 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, including:
  • 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 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 occasion need to wear a PAPR.
• Excellent verbal and written skills
• Excellent interpersonal skills
• The position will require up to 15% percent 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.

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.

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. Additional details can be found on our careers website: www.alkermes.com/careers#working-here