Director, Corporate Compliance and Regulatory Intelligence

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

The Director, Corporate Compliance and Regulatory Intelligence is responsible for the management/execution of corporate audits and provides expertise to sites and the global organization on GMP compliance and best practices; regulatory filing requirements, as well as new and developing regulatory and normative requirements/trends; and complaints.

This position develops and leads the global inspection readiness program, facilitating awareness training and mock inspection activities as appropriate.  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 trends across inspections, audit findings, and other quality systems-related data.  This role is responsible for the business process ownership of the audit program and associate quality records. This data feeds into risk assessment activities across the QMS and is communicated to the Sr. Management team within AGC Biologics. 

PRINCIPAL RESPONSIBILITIES:

• Develop corporate audit plans based on risk assessments, taking into account current regulatory trends and business needs.

• Execute corporate audits/assessments and produce timely reports.

• Communicate identified deficiencies and compliance risks to the appropriate business and quality heads.

• Establish and manage an inspection readiness program, including a process for global review of regulatory inspection responses.

• Conduct pre-inspection “mock” audits as needed

• Advise and 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.

• Globally responsible for compliance with regulatory standards, translating information from Regulatory Intelligence into practical, deployable business business-effective solutions, collaborating with all stakeholders.

• Responsible for the creation of the Global Compliance or Quality Improvement Plan, ensuring these are developed, tracked, and performance reported.

• Analyze and/or perform metrics of regulatory, corporate audits, and critical client audits received across all sites to capture trends and continuous improvement opportunities.

• Establish a continuous improvement and maintenance global platform for reporting, reviewing, and trending Quality Compliance risks on a global basis.

• 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 clients with strategic regulatory intelligence and guidance for product development through registration.

• Owns the business process, associated quality system tools, and records associated with the process.

• Provides ownership of Deviations, CAPA, change records, audit records, and complaints.

• Travel as required, both domestically and internationally, to ensure compliance to the Company’s Quality Management Systems and execute audits as required to support the corporate audit requirements program.

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:

• 15+ years of experience in biotech and/or pharmaceutical manufacturing

• 10+ years of experience in quality operations (QA, QC, Quality Systems) within the biopharmaceutical and/or pharmaceutical industry

• 5+ years of experience in a 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

• Experience supporting regulatory filings (e.g., INDs, BLAs, etc.) and leading product-related inspections for US and foreign regulatory agencies, especially EMEA and Japan.

• Experience hosting regulatory inspections

• Experience in Data Integrity Requirements

• 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 network needs

• Technical background in protein development is preferred

• Requires a bachelor's or advanced degree or equivalent combination of education and experience

COMPENSATION RANGE:

$142,960 - $196,570
 

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

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.