Director Regulatory Compliance

Charles River Laboratories • Wayne, PA

210d • $170,000 - $190,000

About The Position

Responsible for managing the Quality Assurance program(s) at one or more Charles River operations and serves as a member of the Regulatory Affairs and Compliance management team. Provides direction in implementing the Charles River Compliance Program and may lead corporate quality initiatives to improve the program.

Requirements

• Education: Bachelor's degree (B.A. /B.S.) or equivalent. Advanced degree in biological sciences, pharmaceutical sciences, or computer sciences preferred.
• Experience: Ten to twelve years related experience in the pharmaceutical, and/or biotechnology based industry.
• Strong experience and direct responsibility for management of Quality Assurance programs.
• Extensive experience with management of government regulatory inspections and preparing/reviewing responses to any inspectional findings.
• Excellent knowledge of pertinent national and international regulations pertaining to the pharmaceutical and biotechnology industries.
• Excellent leadership and communication skills.

Responsibilities

• Communicate all identified compliance and quality risks to his/her supervisor.
• Develop departmental policies and procedures and assure their consistency with Quality Assurance programs at other Charles River sites/operations.
• Identify the need for Corporate Quality and Compliance Policies and lead development and implementation efforts.
• Direct site/operation Quality Assurance program to assure inspections and audits are accurate, thorough, timely, and provide the correct interpretation of regulatory requirements and corporate policies.
• Maintain a close working relationship with site/operation management to assure a cohesive approach to regulatory compliance.
• Assure staff receives appropriate regulatory and management training, and mentoring to enable the execution of regulatory and management responsibilities.
• Assume a lead role in the development and presentation of regulatory training for Quality Assurance and operations staff.
• Manage site/operation Quality Assurance inspection and audit programs and schedule resources to assure efficient and effective operation of the site/operation Quality Assurance organization.
• Monitor the effectiveness of subordinate Quality Assurance managers in reviewing Quality Assurance reports of audits and inspections to assure proper and consistent interpretation of regulatory requirements and corporate policies.
• Identify and resolve inconsistencies between Quality Assurance audit teams should they occur.
• Assure that all records and reports are prepared, communicated, and retained in accordance with applicable regulatory requirements.
• Serve as the principal liaison with site operations managers to identify regulatory deficiencies, explain audit findings, resolve escalated conflicts, and consult on corrective and preventative actions.
• Assemble, evaluate, and report site metrics measuring compliance and quality key performance indicators.
• Serve as the principal site representative for scheduling and management of regulatory and client inspections/audits.
• Interact, as appropriate, with regulatory agencies in developing a positive working relationship.
• Train site/operation personnel and management on interacting with client and regulatory auditors prepare appropriate summaries and reports of such audits.
• Review and endorse regulatory and client audit responses and corrective action commitments.
• Monitor site/operation corrective actions commitments and communicate 'at risk' commitments to management with recommendations for their timely resolution.
• Identify practices, methods, and processes for improvement and assist other operations on related compliance issues.
• Provide regulatory guidance to internal departments for the development of new products, test methodology, new facility construction, and new processes.
• Participate in development and revision of regulatory submissions, e.g., license applications, supplements, annual reports, and master files.
• Participate in the review and development of quality agreements with clients and contract service providers.
• Assure vendors and suppliers identified/designated by Charles River are assessed for the compliance with applicable regulatory requirements.
• Assume a key role in designated Regulatory Affairs and Compliance projects and programs.
• Participate in Corporate Quality Meetings, Regulatory Affairs and Compliance meetings, intranet communications, and relevant strategic planning sessions.
• Assure that Corporate Quality and Compliance Policies are implemented and administered at the site/operation.
• Direct activities of assigned group(s) to ensure optimum performance of the group/function.
• Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.
• Develop short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
• Integrate activities with those of other major organizational units (e.g. segments, departments, functions).
• Develop and recommend departmental budget and authorize expenditures.
• Develop and oversee the implementation of departmental training programs, including orientation.
• Support the policy of equal employment opportunity through affirmative action in personnel actions.
• Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
• Perform all other related duties as assigned.

Benefits

• Bonus/incentives based on performance
• 401K
• Paid time off
• Stock purchase program
• Health and wellness coverage
• Employee and family wellbeing support programs
• Work life balance flexibility

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees