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, Quality Assurance Operations a full-time position located at the AGC Biologics facility located in Bothell, Washington.  The primary focus for this role is to lead the Quality Assurance (QA) Operations team to ensure site operations remain compliant and decision making for manufacturing, testing and disposition are robust and within regulatory requirements.  This position includes areas of responsibilities in Lot Disposition, Client Interface, Quality Assurance Engineering, Raw Material Disposition, Deviation Management, and In-Plant Quality Assurance Operations.  The position has the ability to grow and mature the current quality operations procedures, management, and tools and develop team and staff members.

KEY RESPONSIBILITIES:

  • Responsible for quality operations department and team in support of AGC Manufacturing, Testing, and Disposition.
  • Lead and drive accountability of a diversified team of Quality professionals responsible for cGMP manufacturing of clinical and commercial products, including but are not limited to: raw materials/ drug substance batch record review and lot disposition, QA oversight of manufacturing activities, QA representative with customers, QA approval of product and process specific documents, QA oversight of site deviation review and approval and QA oversight of the construction, commissioning, qualification, and validation of a commercial manufacturing facility and the subsequent process validation activities.
  • Conduct management responsibilities in accordance with company policies and applicable laws. Recruit, coach and develop organizational talent to ensure scalable growth. Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Manage performance of personnel towards department and Company goals, including feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance, etc.
  • Make and execute operational decisions with a strategic perspective
  • Support operations in continuous improvement initiatives by providing direction on requirements for proposed changes
  • Communicate strategic direction, quality policies/procedures and effectiveness of the Quality System at Management Reviews
  • Promote a culture of quality and accountability mindset, including continuous improvement through the establishment of KPI metrics
  • Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner
  • Prepare quality documentation, metrics, and reports by collecting, analyzing, and summarizing information and trends including failed processes, target turnaround times and disposition dates, number deviations per batch, Root Cause/CAPA activities, etc.
  • Continually work to improve the effectiveness of QMS through the effective application of quality policies, objectives, audit results, analyses of data, and corrective/preventive actions
  • Demonstrate effective change leadership by building strategic partnerships across functional areas to further departmental and organizational objectives
  • Provide support for internal and regulatory audits and inspections, as required
  • Other duties as may be required, according to the changing needs of the business

KNOWLEDGE, SKILLS & ABILITIES:

  • Must be self-motivated, organized and proactive.
  • Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Development, Engineering, QS, Regulatory, MSAT, etc.).
  • Proven experience successfully managing multiple projects simultaneously.
  • Demonstrated ability to build effective working relationships across departments (MSAT, Process Development, Project Management and Business Development) to support new processes and products.
  • Demonstrated experience leading troubleshooting efforts.
  • Strong communication skills necessary to interact with internal stakeholders.
  • Strong presentation skills.

EDUCATION/EXPERIENCE:

  • BS in Life Sciences discipline such as Biochemistry, Chemistry, Biology or related field required
  • Minimum of 15 years of experience in the biotechnology or pharma industry with experience in biologics
  • Minimum of 10 years of experience in managing staff
  • Strong experience and thorough understanding of Quality Systems and risk management tools with in-depth knowledge of cGMPs and applicable FDA regulations guidelines and industry best practices.
  • Experience with relevant analytical lab equipment and computers
  • Must have experience writing, reviewing, approving and managing GMP documentation.
  • 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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