Product Quality Lead

POSITION SUMMARY:

Provide QA Support for the Oral Dosage Manufacturing and Analytical activities at the Waltham site and any related CDMO activities performed externally. Responsible for ensuring development programs are operating in compliance with the EU/FDA regulatory requirements and in compliance with company standards. 

ESSENTIALS AREAS OF RESPONSIBILITY:

• Serve as quality assurance support and SME for development drug substance and drug product & OSD manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing storage and shipping activities are compliant. 
• Responsible for reviewing contractor documents i.e. batch records, deviations and change controls to ensure they comply with Alkermes requirements. 
• Responsible for batch disposition of drug substance & drug product. Accountable for the on-time disposition of in line with the agreed schedule 
• Act as the quality contact for CMO’s maintaining oversight at those CMO’s for quality related topics
• Support testing laboratories (internal and external) in establishing quality systems and QA oversite for Phase III, PPQ through commercialization for biologics.
• Partner with colleagues to develop and negotiate quality agreements.
• Lead quality risk management activities both internal development programs and at the contract manufacturers organization and manage mitigation plans with the CMO. 
• Support all PPQ process and product related activities for drug substance e.g. process characterization, cleaning validation, process validation (including e.g. stability studies, hold time studies, review and approval of protocols). 
• Preparation and development and maintenance of key performance indicators for the development and external quality biologics program to align with the company’s quality objectives. Analysis of quality statistics (Pareto Analysis) to drive improvements. 
• Provide quality direction and input at the change review board and assume QA oversight of change controls ensuring scope of the record is clear and implementation activities are robust and timely. 
• Ensure compliance of quality systems other applicable regulations/standards and internal procedures. Support implementing improvements at the CMO in deviation and changer control systems. 
• Provide the requisite quality support to the regulatory/CMC group in support of licensee applications 
• In conjunction with the supplier quality group ensure all quality agreements are aligned with the requirement expectation from the CMO and CTO organizations. 
• Keep up to date with FDA/EU regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance for clinical commercialization. 
• Build strong effective working relations with CMO’s from a quality and compliance prospective. 
• Proactively support regulatory inspections at the CMO sites that may impact compliance status or require regulatory notifications. 
• Provide quality leadership for change management and significant deviations at CMO sites
• Provide Quality leadership for customer complaints as applicable.  

 QUALIFICATIONS:

Minimum Education & Experience Requirements:

• BS in scientific discipline or equivalent.
• 10-15 years’ experience in the pharmaceutical industry; preferably in biologics drug substance processing
• Experience in development/CMO operations preferred
• Ability to interact effectively with health authorities 

Knowledge/Skills Needed:

• Strong communication skills and an ability to influence key stakeholders
• 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 
• Excellent verbal and written skills 
• Excellent interpersonal skills 
• The position will require up to 20% 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.
• Customer service mindset
• Identifies opportunities to improve and contributes to problem solving.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

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