Job Description

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.

The position ensures that qualification and validation lifecycle activities are scientifically sound, risk-based, compliant with applicable global regulatory requirements, and aligned with Alkermes procedures and Quality standards. The role provides expert input across process validation, equipment, facility, utility and automation qualification, packaging validation, shipping qualification and validation, technology transfer, change control, and lifecycle management.

The position combines external oversight with hands-on technical involvement. It is expected to independently assess complex technical issues, provide risk-based recommendations, and, where required, generate, review, and approve qualification and validation lifecycle documentation. The role requires sound scientific and engineering judgement and the ability to influence technical decisions across internal functions and external partners without reliance on direct authority. The position may supervise one assigned employee and provide technical direction to contractors or consultants, but is primarily a senior technical expert role.

1. Qualification & Validation Governance

• Serve as the primary Qualification and Validation Subject Matter Expert within Development & External Quality.
• Provide independent technical oversight and expert review of qualification and validation strategies supporting Alkermes products across internal operations and external manufacturing partners.
• Ensure qualification and validation activities are planned, executed, documented, and maintained in accordance with applicable regulatory requirements, industry standards, Alkermes procedures, and Quality expectations.
• Promote scientifically sound, practical, and risk-based lifecycle approaches to qualification and validation.
• Support the development, maintenance, and continuous improvement of Alkermes qualification and validation procedures, standards, templates, and lifecycle approaches.
• Drive consistent application of qualification and validation principles across products, projects, the Waltham site, and external manufacturing partners.
• Maintain current knowledge of evolving regulatory expectations, industry standards, and best practices, and identify and communicate significant qualification or validation risks to Quality leadership.
• Provide independent technical challenge where a proposed qualification or validation approach is not adequately supported, scientifically justified, or commensurate with risk.

1. External CMO Qualification & Validation Oversight

• Provide Quality oversight and technical review of qualification and validation activities performed at CMOs supporting Alkermes development and commercial products.
• Oversee Drug Substance and Drug Product process validation, including Process Performance Qualification (PPQ), Continued Process Verification (CPV), and other process validation lifecycle activities.
• Oversee packaging equipment qualification and packaging process validation, cleaning validation or verification where applicable, and qualification of facilities, equipment, utilities, process automation, where relevant to Alkermes products.
• Evaluate the adequacy of CMO qualification and validation strategies and lifecycle approaches.
• Review and approve Validation Master Plans, validation plans, protocols, reports, risk assessments, and other relevant lifecycle documentation.
• Review validation data and conclusions to confirm that acceptance criteria have been met and that conclusions are scientifically justified.
• Review and approve validation-related deviations, investigations, corrective and preventive actions, and associated technical assessments.
• Participate in CMO site visits, audits, technical reviews, project meetings, and Quality governance forums where validation expertise is required.
• Provide technical support during preparation, execution, and assessment of engineering, demonstration, PPQ, and other validation batches, and escalate significant technical, compliance, scheduling, or supply risks.

1. Waltham Qualification Program & Lifecycle Documentation

• Provide technical oversight and direct support for qualification of Waltham facilities where applicable, development equipment, facilities and utilities, process automation, within role scope, facility modifications, and capital projects.
• Establish and document qualification requirements using a science and risk-based lifecycle approach.
• Review and approve qualification plans, assessments, specifications, protocols, reports, discrepancies, deviations, periodic reviews, and associated lifecycle documentation.
• Where required, generate qualification and validation lifecycle documents, including Impact Assessments, Risk Assessments, System-Based Risk Assessments, User Requirements Specifications, IQ/OQ/PQ protocols, qualification reports, traceability documentation, periodic reviews, requalification assessments, technical justifications, and validation position papers.
• Provide technical oversight during execution of internal qualification protocols and hands-on support for critical or complex qualification activities where required.
• Review qualification evidence and test results and support resolution of discrepancies, protocol deviations, unexpected results, and equipment or system performance issues.
• Coordinate and oversee contractors and consultants supporting internal qualification activities.
• Ensure qualified facilities, systems, equipment, utilities, and automation remain in a controlled and qualified state throughout their lifecycle and that documentation remains complete and inspection ready.

1. Change Control Review & Approval

• Serve as the Qualification and Validation representative for internal and external change management activities.
• Review and approve Waltham change controls to identify and assess potential qualification, validation, and lifecycle impacts.
• Review and approve CMO change controls that may affect Alkermes products, processes, packaging operations, or the validated state.
• Determine whether proposed changes require qualification, requalification, validation, revalidation, comparability assessment, enhanced monitoring, or other controls.
• Assess potential impact on process performance, product quality, control strategy, validated state, regulatory commitments, and ongoing lifecycle monitoring.
• Ensure qualification and validation requirements are clearly defined in implementation plans and confirm satisfactory completion before change control closure.
• Provide technical recommendations and risk-based justification for change control decisions and escalate changes presenting significant product quality, compliance, technical, or supply risk.

1. Technology Transfer & Commercialization Support

• Serve as the Qualification and Validation SME for technology transfer activities involving Alkermes products.
• Provide validation input throughout transfer planning, recipient-site assessment, process transfer, scale-up, process characterization, engineering batches, PPQ, and commercial readiness.
• Collaborate with Pharmaceutical Development, Technical Operations, Supply Chain, Regulatory Affairs, and Quality Assurance to define qualification and validation requirements for the transferred process.
• Assess recipient-site capabilities and the proposed validation strategy to confirm suitability for the product, process, development stage, commercial phase, and associated risks.
• Provide input to transfer plans, gap assessments, risk assessments, transfer protocols, reports, and governance reviews from a qualification and validation perspective.
• Evaluate the qualification status and suitability of recipient-site facilities, equipment, utilities, automation, packaging systems, and supporting infrastructure.
• Ensure process knowledge, critical process parameters, critical quality attributes, control strategies, and identified risks are appropriately reflected in the recipient-site validation approach.
• Provide technical guidance on PPQ strategy, including number of batches, scale, sampling, testing, acceptance criteria, deviation management, and enhanced monitoring, as applicable.
• Review and approve relevant recipient-site qualification and validation documentation and support or oversee engineering, demonstration, PPQ, and commercial readiness activities at the recipient site as required.
• Ensure identified validation gaps are tracked and resolved or otherwise appropriately managed before completion of transfer and transition to routine manufacture, and provide input to post-transfer CPV and lifecycle management.

1. Process, Packaging & Shipping Validation Lifecycle Oversight

• Provide technical expertise and Quality oversight for Drug Substance and Drug Product process validation throughout the product lifecycle.
• Review and approve process validation strategies, PPQ protocols and reports, associated risk assessments, sampling plans, acceptance criteria, and scientific or statistical approaches.
• Assess whether validation strategies are supported by available process development, characterization, scale-up, engineering, and manufacturing knowledge.
• Review significant process validation deviations and assess potential impact on PPQ conclusions, product quality, regulatory commitments, and validation status.
• Provide technical input to CPV strategies and periodic assessment of process performance and determine whether adverse trends, process changes, or recurring deviations require further action or revalidation.
• Provide technical oversight for packaging equipment qualification and packaging process validation supporting clinical and commercial products, including validation impact assessments for equipment, component, configuration, process, site, or line changes.
• Provide technical oversight for shipping qualification and transportation validation of API, Drug Substance, Drug Product, clinical supplies, and commercial finished goods.
• Develop, review, and approve shipping qualification strategies, protocols, reports, risk assessments, route or lane qualification requirements, technical justifications, and lifecycle assessments.
• Support assessment of temperature excursions and other transportation events and provide validation input for distribution changes, market expansion, new routes, and new external partners.

1. Validation Risk Management & Technical Assessment

• Lead or support risk-based assessments used to determine qualification and validation requirements for facilities, systems, equipment, utilities, processes, packaging operations, automation, and transportation systems.
• Apply scientific and engineering knowledge to identify critical functions, requirements, parameters, failure modes, and controls.
• Critically evaluate qualification and validation strategies and recommend improvements where approaches are not adequately supported or proportionate to risk.
• Support development and maintenance of impact assessments, system-based risk assessments, failure mode assessments, and other risk management tools.
• Translate complex requirements into practical, risk-based solutions and clearly document technical decisions, assumptions, conclusions, and residual risks.
• Provide technical input into investigations involving qualification or validation issues.

1. Inspection Readiness, Cross-Functional Support & Governance

• Serve as the Qualification and Validation SME during regulatory inspections, partner audits, and internal audits.
• Support inspection and audit preparation, present qualification and validation strategies and evidence, and contribute to responses, commitments, and remediation activities.
• Ensure qualification and validation records meet applicable data integrity and documentation requirements and remain complete, accurate, readily retrievable, and inspection ready.
• Provide qualification and validation expertise to Pharmaceutical Development, Technical Operations, , Supply Chain, Regulatory Affairs, and Quality teams.
• Support product development, scale-up, technology transfer, new product introduction, commercialization, process improvement, facility modifications, capital projects, and lifecycle management.
• Participate in project, Quality, and technical governance forums and communicate significant risks, decisions, dependencies, and required actions clearly and promptly.
• Balance compliance, scientific, operational, and business considerations while maintaining product quality and patient protection as the primary priorities.

1. Coaching, Supervision & Knowledge Development

• Provide technical mentoring and guidance to validation, Quality, and cross-functional personnel.
• Provide direct supervision, objective setting, performance feedback, and development support for assigned personnel, where applicable.
• Provide technical direction to contractors and consultants supporting qualification and validation activities.
• Support development of validation-related training and guidance and share technical knowledge, best practices, and lessons learned across internal teams and external partners.
• Promote consistency in interpretation and application of qualification and validation requirements and foster a culture of Quality, scientific rigor, accountability, collaboration, and continuous improvement.

1. Travel & On-Site Support

• Travel domestically and internationally to Alkermes sites, CMOs, contract packaging organizations, and other external partners as required.
• Provide on-site technical support or oversight during CMO process validation and PPQ, technology transfer, engineering and demonstration batches, commercial readiness activities, equipment, facility, utility, automation and packaging qualification, Waltham internal qualification execution, shipping qualification studies, investigations, technical reviews, audits, governance meetings, and regulatory inspections.
• Travel may be required during critical project or validation execution periods and may involve extended on-site support depending on project needs. Anticipated travel is approximately 15% to 30%, subject to business and project requirements.

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.