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Associate Director, Quality Product Lead

2 months ago

Oklahoma City, United States HireMinds Full time

Our clinical stage pharmaceutical client here in Boston, MA is growing and looking to add an

Associate Director, Product Quality Leadership

(REMOTE) to their team This role will provide oversight of GMP product quality and work in partnership with Technical Operations, Quality Control, Regulatory Affairs, and GMP suppliers to assure compliance with quality standards and global regulatory authority expectations. Director will identify and mitigate product quality and regulatory compliance risks, as well as working in partnership with Regulatory Affairs to ensure compliance with applicable global regulations. In addition to having quality oversight for in-depth end to end technical knowledge of products, will act as key Quality partner with other company functional areas, third parties and partners. Other responsibilities include but not limited to:

Provide direct QA oversight and support for the assigned area (e.g. Product Quality)

Provide QA input for tech and analytical transfer/validation activities, deviation and OOS investigations that require oversight of product quality, stability studies, reference standards, specifications, procedures, and processes, etc.

Serve as quality lead for product/program teams, including quality lead for CMC regulatory filings

Ensure all processes contributing to the clinical supply, are conducted in a compliance with applicable regulations and requirements

Responsible for compliant, thorough, and accurate review of analytical and process documents, including QA oversight of investigations within specified area of Product Quality

Review and approve SOP’s, specifications, and other CDMO and internal controlled documents

Supports the development and maintenance of quality systems supporting GxP operations.

Provides Quality oversight or ownership Quality records (e.g. Investigations, CAPA, Change Controls, SOPs, Quality Plans, Risk Assessments)

Requirements:

Minimum of a bachelor’s degree in biological sciences; advanced degree in biological sciences desirable

A minimum of 8 years’ experience in a pharmaceutical/biologics company with at least two (2) years of leadership experience

Experience with third party QA desired

Experience with biologics/vaccines is required

Strong understanding of GMP Quality for pre-clinical, clinical, and commercial stage work

Demonstrated ability to apply pharmaceutical industry regulatory compliance requirements with an emphasis on US and EU GMP regulations

Highly skilled in root cause investigations, change control, commercial manufacturing oversight and regulatory inspections

Ability to establish and maintain good working relationships with other functions and levels within the company and with external groups and organizations (vendors, investigators, regulatory authorities, and other stakeholders)

Other:

Willingness to travel (20-25%) to various meetings or third-party sites, including overnight trips

Some international travel may be required

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