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 Corporate Quality Control Dir/Sr. Dir is responsible for managing the development and implementation of Global Quality Control Systems across all AGC Biologics sites.    This includes the establishment of global policies, procedures, guidances, training and other tools required for its global deployment. In addition, this position will support with the harmonization or improvement of other laboratory systems such as Investigations, Data Trending, Raw Material Qualification Program, LIMs and other critical systems/processes.

PRINCIPAL RESPONSIBILITIES:

  • Establish controls, global policies, procedures or guidance documents to define and align the operations of all Quality Control activities globally for internal and external testing activities.
  • Establish procedures that define the method validation and verification activities, and method transfer between sites
  • Support sites with the implementation of technology solutions for processes used across the Quality Control and Facility operations including LIMS, equipment-LIMS interfacing, testing/liquid handling automation system, micro rapid testing, data acquisition systems and others.
  • Support the automation of data gathering, processing and information management in support of Quality compliance, operational KPIs trending and issuance of periodic trending reports.
  • Drive quality control continuous improvement initiatives to enhance productivity and efficiency of QC operations globally. This may include assess test demand/capacity, testing cycle time reductions, etc.
  • Support sites as needed in interactions with other key functional units as well as with external contract testing labs.
  • Provide guidance on the management of deviations, CAPAs, OOS/OOT investigations, and change controls initiated in the laboratory. Review laboratory deviation evaluation and resolution activities as required.
  • Develop a Quality Control Global Community and serve as Global SME for this system. Lead and /or Provide mentorship to site representatives.
  • Conduct GMP Corporate Audits sites and as needed of external testing laboratories.
  • Serve as an SME during regulatory inspections.
  • Travel as required, both domestically and internationally, to ensure compliance to the Company’s Quality Management Systems.

KNOWLEDGE, SKILLS & ABILITIES:

  • Demonstrated leadership in Quality & Compliance discipline and in-depth knowledge of global health authority regulations and requirements, with the ability to effectively translate and communicate these requirements into effective global procedures/policies.
  • Subject matter expertise in global regulatory requirements and expectations as defined by pharmaceutical regulatory authorities.
  • Experience performing audits and hosting regulatory inspections.
  • Excellent facilitation and project management skills, with strong verbal and written communication skills.
  • Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management.
  • Must be capable of effectively presenting information to senior management, peers, clients and regulatory authorities

EDUCATION/EXPERIENCE:

  • 15+ years of experience in biotech and/or pharmaceutical manufacturing
  • 10+ years of experience in QC and/or Microbiology within biopharmaceutical and/or pharmaceutical industry
  • 5+ years of experience in global or corporate Quality function
  • Strong strategic understanding and working knowledge of Quality Systems (FDA QSIT and ICH Q10) and how those systems are implemented to meet FDA, EMA and other major jurisdictional requirements
  • Exceptional customer interface skills are required
  • Ability to work hours necessary to support global network needs and travel both domestic and international ~20%
  • Requires bachelor or advanced degree or equivalent combination of education and experience

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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