"Alerted.org

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

The Senior Director Global Head of Biologics Testing Quality will provide direction and leadership as regulatory Subject Matter Expert in Biologics Testing Quality Systems and provide guidance and support for multisite Biologics Testing (BLX) compliance program designs and/or QA/QC activities. The individual will have oversight of various business unit QA/QC teams to establish/improve the Quality Units regulatory knowledge and either establish or improve quality systems and processes specific to the testing platforms supporting GMP activities while ensuring compliance with all appropriate worldwide governmental regulatory agencies (FDA, EMA, HPRA, etc.) and corporate policies to avoid any business interruption. This leader will be a key contributor to engaging clients and new customers in establishing our Quality organization support and protocols.

Essential Duties and Responsibilities

• Provide input into the development of regulatory strategy, objectives, and processes across the Biologics Testing Business Units and with CDMO/Microbial business partners that fundamentally raise the importance of quality/compliance within the organization. Work directly with senior corporate operations management teams to ensure regulatory compliance and consistency with Charles River policies and procedures.

• Oversight of Biologics Testing QA Business Units; assess that Quality Management Systems (QMS) meet regulatory requirements and that processes and systems are efficient and effective.

• Interact with clients, regulators and/or industry experts to represent CRL interests, as appropriate.

• Serve as the coordination contact for governmental regulatory agencies (i.e. FDA, HPRA, EMA and other agencies) relating to such matters.

• Build an environment to optimize employee compliance and add quality culture values to the organization by actively providing guidance or input into business team meetings.

• Provide assistance with the development and implementation of global GMP training programs to provide compliance managers and staff in designated staff functions and/or businesses with the knowledge and experience to advance the strategic objectives of the Corporate Compliance Program. Identify emerging issues and the training experiences necessary to enable the staff in addressing these issues at the various global sites.

• Provide input and guidance for Computer System Validation activities, ensuring the strategies and processes are aligned with corporate regulatory policies and are aligned globally from a quality perspective.

• Foster a culture of continuous improvement within the QA organization.

• Recruit, develop, and lead high-performing QA teams, fostering/creating a positive and collaborative team culture in support of the CRL Values of Lead, Own, Collaborate and Care

• Collaborate with stakeholders, implement test automation strategies, monitor performance metrics, and ensure regulatory compliance to drive effective quality assurance processes.

• Perform a continuing program of review and analysis of QA functions and findings. Track and assess all critical audit findings from internal and external sources.

• Direct due diligence assessments of potential business acquisitions and dispositions and prepare recommendations to executive management.

• Review commitments to clients and domestic and international regulatory agencies, including responses to domestic and international regulatory inspection findings, Warning Letters, and untitled letters, to assure corrective and preventive actions have been fulfilled.

• Coordinate the development and/or revision of harmonized quality assurance procedures affecting multiple sites.

• Serve as consultant to all company divisions on related quality and regulatory issues.

• Provide regulatory guidance to internal departments for the development of new products, test methodology, new facility construction, and new manufacturing process.

• Develop short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.

• Perform all other related duties as assigned.

Job Qualifications

• Education: Bachelor's degree (B.A. /B.S.) or equivalent in scientific discipline or related field. Advanced degree in biological sciences, pharmaceutical science or computer sciences preferred.

• Experience: Fifteen (15) or more years related experience in a pharmaceutical and/or biotechnology-related industry having direct responsibility for QA/ Quality Control/Regulatory Affairs. Minimum of 5 years oversight of multiple Global Operations sites.

• Ability to build strong relationships and collaborate effectively across departments.

• Experience with Strategic M&A integrations

• In-depth knowledge of GMP, governmental regulations, and other relevant quality standards.

• 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

• Travel requirements: 20%- 30% domestic and international

• Other: In-depth knowledge of 21 CFR Parts 11, 210, 211, 600 series, 800 series and related guidance documents (US and OUS) as well as FDA and USDA regulations and International Council on Harmonization (ICH) guidelines. Excellent verbal and written communications skills required.

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 in the work environment is usually quiet.

Comments:

• This position requires regular domestic and international travel.

Compensation Data

The base pay range for this position is 200,000.00 - 240,000.00. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.

About Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

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 over 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.

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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past 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 [email protected]. 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.

227609