Director Regulatory Compliance Position Available In Delaware, Pennsylvania

Director Regulatory Compliance 3.1 3.1 out of 5 stars Wayne, PA 19087 For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about. 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. About Microbial Solutions Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion. At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in the last five years. We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity Employer – all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit www.criver.com. 228761