Assoc Dir, Quality Assurance Operations

POSITION SUMMARY:

The Associate Director, Quality Assurance Operations (Waltham) reporting to the VP Quality, Development and External, is responsible for providing onsite QA operational oversight for clinical phase Oral Dosage Manufacturing at Alkermes Waltham facility, ensuring that every aspect of manufacturing meets predefined standards of quality such that drug product is produced consistently and meets the stringent requirements necessary for clinical trials. This includes overseeing manufacturing processes, testing, and ensuring adherence to established Batch documentation, protocols and SOPs such that all operations comply with EU /FDA regulatory standards.

ESSENTIALS AREAS OF RESPONSIBILITY:

• QA management of onsite support of clinical phase oral dosage drug product manufacturing, testing and storage, 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:
• QA management and oversight of review and approval of site documentation such as; Master batch production records; Executed batch production records; Analytical Records, Cleaning Verification Protocols; Quality Risk Assessments; GMP SOPs;
• Liaise with other Alkermes QA functions as required to support on site activity
• Liaise with Analytical Development, Process Development, Alkermes QPs, other QA teams, to resolve any discrepancies noted during batch record review.
• QA management and oversight and review and approval of site generated deviations and change controls
• QA management and oversight of site batch production record reports to support batch disposition by Alkermes QPs.
• Manage QA site support of Alkermes QPs related to batch disposition.
• Manage batch disposition metrics and KPIs to monitor batch disposition process performance.
• Manage QA support for GMP manufacturing, including line clearances and other on floor production support to ensure manufacturing operations are conducted according to appropriate cGMP behaviors and in compliance with SOPs, batch manufacturing records and other cGMP documentation as applicable.
• Identify continuous improvement opportunities to ensure batch disposition processes are efficient and remain in a constant state of compliance.
• Provide QA support as required to the regulatory/CMC group in support of regulatory filings for Phase I/II oral dosage drug products manufactured on site.
• Provide support for clinical complaints for drug products manufactured on site as applicable.
Provide support for internal audits as required.

QUALIFICATIONS:

Minimum Education & Experience Requirements:

• BSc. in scientific discipline or equivalent.
• Minimum of 10 years’ broad experience in the pharmaceutical industry; preferably in Oral Solid Dose with strong background in associated manufacturing, analytical testing 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
• Experience in pharmaceutical product development for oral sold dosage products
• 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
• 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.
• Comfortable working in a fast-paced environment with multiple issues open simultaneously.
• 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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