Director, Quality Assurance Operations

Company: AGC Biologics
Location: Boulder
Posted on: September 12, 2020

Job Description:

AGC Biologics  is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On Time. For more information, visit www.agcbio.com .

SUMMARY:

The  Director of Quality Assurance (QA) Operations  is accountable for leading and managing the day-to-day activities of the QA Operations department. The position will help drive the development and management of the QA organization for a new Biologics facility. The site’s business objectives focus on advancing development products through commercialization and commercial manufacturing. The Director will be responsible for QA lot disposition, raw material release and provide QA support and oversight of manufacturing, facilities, and QC.

PRINCIPAL RESPONSIBILITIES

Supports development of policies, processes, procedures and controls ensuring that performance and quality of products conform to established cGMP standards and regulatory requirements

Develops, implements and maintains processes to support lot disposition and raw material disposition for clinical and commercial Biologics production

Manages QA support for the review and approval of documentation such as batch records, process and equipment validation protocols and reports, product specifications and change controls

Evaluates proposed process changes and improvements. Ensures proposed process changes are consistent with applicable regulatory guidelines and assures changes that affect a regulatory submission or require communication to regulatory authorities are appropriately conveyed.

Provides expertise and guidance in interpreting existing and emerging governmental regulations, agency guidelines and internal policies to assure compliance

Leads and supports investigations associated with major deviations in operations

Represents company in dealing with clients and supports implementation of Quality Agreements

Partners with Manufacturing and QC to enhance the GMP compliance profile of the site by ensuring the timely closure of investigations and implementation of appropriate corrective actions

Ensures that all trends are evaluated, that root causes are identified and corrective actions are implemented

Authors, reviews and / or approves internal quality documents (SOPs, deviations, CAPAs, change controls, etc.) and external regulatory agency documents

KNOWLEDGE, SKILLS & ABILITIES:

Ability to understand and apply GMP regulations as they relate to manufacturing, testing and facility operations

Demonstrated ability to effectively manage multiple tasks utilizing organization and prioritization skills

Strong interpersonal, written and oral communication skills

Strong problem-solving skills

Strong management, staff development and mentoring skills

EDUCATION / EXPERIENCE:

BS in Physical Sciences, Life Sciences or Engineering; advanced degree is preferred

15+ years of relevant experience in a biotechnology and GMP environment

Experience with QA and GMP compliance in clinical and commercial Biologics drug substance manufacturing

Equivalent education and experience may substitute for stated requirements

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

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Keywords: AGC Biologics, Boulder , Director, Quality Assurance Operations, Other , Boulder, Colorado