Director, GMP QA NA Biologics - United States
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- Direct the development and administration of the Quality Assurance (QA) programs in support of the North American (NA) Biologics business for current Good Manufacturing Practices (cGMP) manufacturing and contract laboratory services.
- Ensure compliance with all federal, state and corporate policies to avoid any business interruption.
- Provide direction and leadership in the development and implementation of quality systems in support of GMP regulations consistent with the Biologics business needs—including, but not limited to, directing and implementing the harmonization of Quality Assurance internal audit and quality system programs across the NA Biologics Operations.
- Develop and direct consistent QA programs within the NA Biologic operation, ensuring compliance with cGMP and other pertinent federal and state regulations, international standards, corporate policies, and customer requirements.
- Working with the Senior Director of Global GMP QA to coordinate site compliance and global quality programs to help assure consistency.
- Provide subject matter expertise and leadership in the development and implementation of critical quality systems in support of the NA Biologics business and cGMP requirements.
- Work directly with NA Biologic General Managers and QA staff to assure regulatory compliance and consistency with company policies and procedures; communicating all identified compliance and quality risks to Biologic management.
- Manage the cGMP NA Biologic QA functions in support of multiple domestic sites/locations.
- Provide recommendations to management and direct the implementation of objectives, goals, policies, budgets and plans for programs and organizational arrangements aimed at the most effective utilization of the NA Biologic business. Review performance against these goals, plans and budgets.
- Responsible for ensuring any post merger integration activities and milestones for the QA group are deployed and effectively managed.
- Provide assistance on global GMP programs/goals to ensure proper harmonization across the sites.
- Participate in the CRL Global QA meeting, Corporate QA/RA policy development, joint Operational/QA meetings and strategic planning sessions.
- Assist in the development and implementation of audit programs, including both internal and external auditing, in support of the NA Biologics business segment.
- Provide regulatory guidance to internal departments for the development of test methodology, new facility construction, new manufacturing process, etc.
- Assure that manufacturing and testing services departments (e.g., cell culture, vaccine manufacture, virology, molecular biology, microbiology, sterility, environmental monitoring, analytical, lot release, etc) operate in compliance with domestic and international GMPs and requirements of all applicable regulatory agencies and groups (e.g., OSHA, USDA and international equivalents).
- Participate in the review and development of quality agreements with clients and contract service providers.
- Direct and administer a continuing program of review and analysis, using metrics, of the quality systems to ensure the quality/reliability of the program.
- Prepare regular compliance reports that advise management of the state of compliance within the NA Biologics facilities.
- Interface as appropriate and maintain positive working relationships with all applicable regulatory agencies (e.g., FDA, EPA, USDA, and their international equivalents).
- Participate in all regulatory communications related to audit responses and corrective action commitments to the agencies.
- Design, plan and operate compliant systems that ensure objectivity while retaining sensitivity to business needs. Interface, as appropriate, with external clients to ensure a clear, mutual understanding of each party’s needs.
- Provide input and quality expertise for all major projects that have a quality impact at NA Biologics sites/locations (e.g. standardizing software platforms for managing quality data or documents, supplier program, internal corporate audit program, etc.).
- Direct and mentor the Quality Assurance staff supporting NA Biologics operations.
- Interview and select qualified exempt-level departmental personnel. Recommend, review and approve personnel actions, including hiring, promotions and raises. Partner with Human Resources in the handling of disciplinary issues. Prepare and/or approve appropriate personnel action paperwork.
- Identify and develop high-potential employees, through development plans, in support of the company’s succession planning process.
- Ensure that management training and development needs are identified and programs initiated. Direct the development of departmental orientation and other training programs.
- Monitor performance of direct reports. Provide regular coaching and counseling. Prepare and deliver salary and performance reviews; review and approve performance and salary appraisals initiated by direct reports.
- Monitor and determine appropriate levels of departmental overtime. Review and approve vacation/time off requests for direct reports.
- Develop short- and long-range operating objectives, organizational structure, and staffing requirements.
- Oversee the development of a departmental plan for backup and succession of key departmental personnel.
- Develop and recommend departmental budget. Authorize expenditures in accordance with budget.
- Approve budget and expenses of subordinates.
- Ensure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
- Direct the development and communication of departmental systems, SOPs, policies and procedures.
- Partner with Human Resources to develop and approve departmental job descriptions; ensure communication of duties and responsibilities to employees.
- Support the policy of equal employment opportunity through Affirmative action in all personnel actions including but not limited to recruiting, hiring, promotions, training, work assignments, and salary actions etc.
- Perform all other related duties as assigned.
- Education: Bachelor’s degree (B.A./B.S.) or equivalent in scientific or related discipline/field.
- Experience: Ten (10) or more years of related experience in a pharmaceutical and/or biotechnology-related industry having direct responsibility for QA/Quality Control/Regulatory Compliance with a strong emphasis on GMP.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: None.
- Other: IN-depth knowledge of 21 CFR Parts 11, 210, 211, 600 series, 800 series and related guidance documents, as required. Excellent verbal and written communication skills required.
Equal Employment Opportunity