Sr Qualification and Validation Specialist

The Senior Qualification & Validation Specialist is a senior individual contributor and subject matter expert responsible for providing independent technical oversight, Quality governance, and technical direction for qualification and validation activities supporting Alkermes development and commercial programs. The role has primary responsibility for oversight of qualification and validation activities performed at Contract Manufacturing Organizations (CMOs) and for direct technical oversight of qualification activities at the Alkermes Waltham site GMP Manufacturing.

Bachelor's degree in Engineering, Pharmaceutical Sciences, Life Sciences, Chemistry, Biotechnology, or a related scientific or technical discipline required; Master's degree in Validation, Engineering, Pharmaceutical Sciences, or a related discipline preferred.

• Minimum of 10 years of progressive experience in the pharmaceutical or biotechnology industry, with significant experience in qualification and validation in regulated development or manufacturing environments.

• Demonstrated expertise in oral solid dosage process development and manufacturing, including development, scale-up, technology transfer, commercialization, and commercial lifecycle activities.

• Demonstrated experience with process validation, PPQ, CPV, equipment, facility and utility qualification, packaging validation, shipping qualification, automation qualification, and validation lifecycle management.

• Experience developing, reviewing, approving, and executing qualification and validation lifecycle documentation, including impact assessments, risk assessments, system-based risk assessments, protocols, reports, periodic reviews, and technical justifications.

• Experience providing technical oversight of CMO qualification and validation activities and reviewing CMO change controls for impact on the validated state.

• Experience supporting internal change control systems and determining qualification and validation requirements arising from change.

• Strong knowledge of global cGMP requirements and regulatory expectations, including FDA process validation expectations, EU GMP Annex 15, ICH guidance, and relevant ASTM and ISPE lifecycle approaches.

• Ability to critically evaluate technical strategies, data, and scientific conclusions; independently challenge assumptions; and recommend practical, risk-based solutions.

• Strong scientific and engineering judgement and the ability to influence decisions across internal functions and external partners without reliance on direct authority.

• Excellent written, verbal, interpersonal, presentation, technical writing, analytical, problem-solving, risk assessment, project management, organizational, and prioritization skills.

• Ability to operate independently, manage multiple products, projects, sites, and priorities, and collaborate effectively across multidisciplinary teams.

• Experience supporting regulatory inspections and partner or internal audits.

• Experience supervising or technically mentoring employees, contractors, or consultants preferred.

• Ability and willingness to travel domestically and internationally, approximately 15% to 30%, according to business and project requirements.