Director, Regulatory Compliance

The company offers preclinical services to the biopharmaceutical and interventional device industry throughout the US. 

 

BASIC SUMMARY:  

The Director, Regulatory Compliance is responsible for managing the GLP Quality Assurance business operations. Works with President/CEO to ensure consistency with meeting business objectives and for compliance with all federal and state regulations.  Provides direction and leadership in the development and implementation of Quality programs in support of regulatory (GLP/GMP/USDA) requirements.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

? Manage the development, implementation and maintenance of Quality Assurance programs and activities in a regulated environment to ensure compliance with federal/state regulations (e.g. GLP/cGMP and USDA requirements).

? Ensure that objectives of the Quality programs are defined and communicated.

? Maintain a close working relationship with management (direct and indirect reporting relationships) to ensure a unified approach to managing Quality programs.

? Ensure that Quality policies are implemented and administered consistently.

? Supervise and manage direct reports.

? Manage document control functions at site(s).

? Interface with regulatory agencies (FDA, USDA, etc.) to develop positive working relationships and ensure that compliance objectives are met.

? Develop and/or review all site-specific responses to regulatory agency and client inspections and corrective action commitments.

? Ensure QA representation or participation on the IACUC committee for site(s).

? Participate and contribute to all projects having a quality impact (e.g. validation projects, regulatory initiatives, audit programs, etc.).

? Participate in QA/RA policy development and relevant QA/RA strategic planning sessions.

? Participate in the development and planning of agency/client inspection readiness training. 

? Conduct training as necessary.

? Direct activities of assigned group(s) to ensure effective performance of function.

? 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. 

? 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.

? 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.

? Perform all other related duties as assigned.

 

QUALIFICATIONS:

? Education: Bachelor's degree (B.A./B.Sc.) or equivalent from four-year college or university in a scientific discipline or related field.

? Experience: Seven to ten (7-10) years related experience in a pharmaceutical, biotechnology and/or biomedical industry having direct responsibility for quality assurance, and/or regulatory affairs with a strong emphasis on GLPs/cGMP/USDA and international regulations. Minimum of three (3) years experience in managing organizations responsible for quality assurance, quality control, and/or regulatory affairs. Minimum of five (5) years experience in interfacing with regulatory agencies (e.g. FDA, USDA, DEA, and EU).

? An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

? Certification/License:  None.

? Other:  Strong leadership ability, communication and facilitation skills required.  Must be an active member of a professional organization specific to quality assurance and federal regulations (e.g. GLP, GMP, etc.).

 

PHYSICAL DEMANDS:

? While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls; talk or hear; and type at a computer or typewriter.

? Specific vision abilities required by this job include close vision, color vision, and depth perception.

 

WORK ENVIRONMENT:

? General office working conditions, the noise level in the work environment is usually quiet.

 

Comments:

? This position may require occasional domestic travel.

 

 The company offers competitive salary and benefits package.