Job Summary

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.

Essential Duties

⦁    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. Align Quality Assurance staffing level and expertise with identified business needs.
⦁    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.
⦁    Serves 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.

Responsibilities:

⦁    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].
⦁    Communicate all identified compliance and quality risks to his/her supervisor.
⦁    Perform all other related duties as assigned.

Job Qualifications

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

PHYSICAL DEMANDS:
⦁    Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.
⦁    Must regularly communicate with employees/customers; must be able to exchange accurate information.
⦁    Must occasionally move about inside the office to access file cabinets, office machinery, etc.

WORK ENVIRONMENT:
⦁    General office working conditions; the noise level is usually quiet.

COMMENTS:
⦁    Requires regular domestic and international travel.

Compensation Data

The pay range for this position is 170K-190K Base and equity eligible (RSUs). Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.