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 and cell and gene therapies. 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 Compliance and Regulatory Intelligence Sr. Mgr. is responsible for surveilling the regulatory environment and providing expertise to sites and the global organization on GMP compliance and best practices; regulatory affairs filing requirements, as well as new and developing regulatory and normative requirements/trends. In addition, this role is responsible for conducting effectiveness checks as appropriate as well as preparing, analyzing and reporting on compliance metrics to identify possible trending across inspections, audit findings and other quality systems related data. This data feeds into risk assessment activities across the QMS and is communicated to the Sr. Management team within AGC Biologics.  This position will also support sites with the execution regulatory inspections or training on this topic.

 

PRINCIPAL RESPONSIBILITIES:

  • Monitor and administer the Redica regulatory surveillance platform for AGC Biologics
  • Identify new regulatory requirements and trends in enforcement actions
  • Communicate identified deficiencies and compliance risks to appropriate business and quality heads.
  • Support sites in the management of regulatory inspections, regulatory responses and other quality management system programs.
  • Participates in due diligence activities related to potential acquisitions and integration activities ensuring compliance and data integrity requirements are appropriately assessed.
  • Analyze and/or perform metrics of regulatory inspections, corporate audits and critical client audits received across all sites to capture trends and continuous improvement opportunities.
  • Support as needed the Global Quality strategy by creating the required policies and procedures related to regulatory compliance.
  • Ensure expertise in GMP and Quality Standards is maintained through involvement in Industry forums and conferences.
  • Establish a Regulatory Affairs support function for the organization to provide client with strategic regulatory intelligence, advice on reporting requirements and regulatory guidance for product development through registration.
  • Support with the execution of regulatory inspections or training on this topic, as needed.

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.
  • 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:

  • 7+ years of experience in biotech and/or pharmaceutical manufacturing
  • 7+ years of experience in quality operations or regulatory within biopharmaceutical and/or pharmaceutical industry
  • 5+ years of experience in global or corporate Quality function
  • Strong 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
  • Experience supporting regulatory filings (e.g., INDs, BLAs, etc.) and participating in product-related inspections for US and foreign regulatory agencies, especially EMEA and Japan.
  • Strong experience preferably in the sterile manufacturing and/or biologics areas
  • Exceptional customer interface skills are required
  • Ability to work hours necessary to support global time zone needs or travel NMT 10%
  • Technical background in protein development is preferred
  • 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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