Director, Quality Assurance Compliance

Essential Functions:

 

  • Leadership
    • Mentor and provide direction to the QA Compliance organization to ensure organization is complying with site and global quality standards, regulatory requirements and partner commitments
    • Collaborate across the organization to implement global and site compliance standards to ensure facility inspection readiness
    • Work with Quality management on staffing of QA Compliance organization
  • Operational Delivery
    • Lead Partner and Agency GMP inspections and manages commitments to corrective actions
    • Direct internal and external audits and maintains audit schedule
    • Collaborate with site leadership and QA Operations to develop and maintain a risk based strategic Compliance plan for the FDBT facilities that will meet US and EU requirements for cGMP manufacturing of drug substance and sterile drug product
    • Support on time release of manufactured products
  • New Business Growth
    • Host due diligence Quality audits
  • Compliance
    • Negotiate Supplier Quality Agreements
    • Negotiate Partner Quality Agreements
    • Review and/or approve basic and complex technical documents, including but not limited to:

Standard Operating Procedures

Change Controls

Deviation and Investigation reports

Annual Product reports

  • Work with Quality management to implement and grow phase appropriate quality systems that will enable cGMP manufacturing of pre-clinical to commercial products
  • Provide daily guidance for the compliance of Facility with international standards and regulations for GMP manufacturing
  • Support Regulatory, client, and internal audits
  • Act as a QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups as requested
  • Promptly notify Senior Management of potential quality or regulatory issues that may affect site or global compliance

 

Required Skills & Abilities:

 

  • Ability and desire to learn and undertake additional leadership responsibilities across all Quality Assurance functions
  • Excellent written and oral communication skills.
  • Excellent organizational, analytical, data review and report writing skills
  • Ability to set personal performance goals and provide input to departmental objective
  • Ability to multitask and easily prioritize your work
  • Ability to work independently with little supervision
  • Proficient in Microsoft Excel, Word and PowerPoint
  • All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products

 

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

  • Experience prolonged standing, some bending, stooping, and stretching
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required
  • Attendance is mandatory

 

Qualifications:

  • BS or equivalent with 6+ years of Quality experience in a regulated pharmaceutical, biotechnology or supporting CMO environment.  Experience with electronic quality management systems.  Strong knowledge of US and European compliance requirements.  Strong knowledge of facility engineering and commissioning, biotechnology manufacturing, utility commissioning, regulatory approval process and requirements.  Direct experience hosting or supporting Regulatory agency site inspections.

 

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We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. 

If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.