For 75 years, Charles River employees have worked together to assist in the discovery, development, and safe manufacture of new drug therapies. 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.
Job Summary
Do you have expertise in working to GMP standards, within a Quality Assurance function?
Are you a motivated people manager, capable of leading teams from the front with the desire to play a key role in career development?
The Site Quality Lead plays a critical role in ensuring compliance with regulatory requirements and maintaining high-quality standards across the site.
This is a fantastic opportunity for a strong people leader who has forged their career within Quality Assurance and Compliance to take the next step and join a fast-paced, global organization dedicated to improving the lives of their patients.
Responsibilities:
In this role, you'll be expected to:
• Develop departmental policies and procedures to assure applicable regulatory requirements are fulfilled.
• Manage direct reports to assure that Quality Assurance responsibilities of applicable regulations are fulfilled.
• Assure staff receives appropriate regulatory training and mentoring to enable the execution of regulatory responsibilities.
• Assist in the development and presentation of regulatory training for Quality Assurance and operations staff.
• Schedule resources to manage compliance systems and assure timely completion of audits of regulatory records and reports, inspections of facilities and equipment, investigations, audits of methods, practices, and controls, review/approval of SOPs, approval of Change Controls.
• Review and endorse Quality Assurance reports of audits and inspections to assure proper and consistent interpretation of regulatory requirements and corporate policies.
• Assure that all records and reports are prepared, communicated, and retained in accordance with applicable regulatory requirements.
• Meet with operations personnel to explain audit findings, resolve conflicts, and consult on corrective and preventative actions.
• Interface with Regulatory Agencies during inspections.
• Administer programs for measuring compliance and quality through pertinent metrics on key performance indicators and provide periodic reports to management.
• Represent the corporation during regulatory and client inspections/audits.
• Prepare site/operation personnel for client and regulatory audits and prepare appropriate summaries and reports of such audits.
• Coordinate the preparation of regulatory and client audit responses and corrective action commitments.
• Track corrective actions and apprise management of their status.
• Assure vendors and suppliers identified/designated by Charles River are assessed for the compliance with applicable regulatory requirements.
• Participate in Regulatory Affairs and Compliance projects and programs.
• Perform general auditing duties for compliance with quality standards.
• Prepare written reports on audit and inspection activities.
• Review SOPs.
• Communicate all identified compliance and quality risks to his/her supervisor.
• Assist with Vendor Assessment, client audits, and subcontractor audits.
• Assure that Corporate Quality and Compliance Policies are implemented and administered at the site/operation.
• Manage activities of assigned group(s) to ensure optimum performance of the group/function.
What We Offer:
We offer a comprehensive benefits package, including a pension contribution, private medical insurance, private dental care, critical illness cover, bonus, and more.
Access to great discounts via our CREDS discount scheme.
Global opportunities and strong career progression.
The chance to work on several varied projects and liaise globally and nationally with other business areas.
To make a difference to health and well-being of people.
To continue your own career growth.
Flexible and hybrid working.
Parental leave.
Well-being support and initiatives.
About Biologics Testing Solutions:
The Charles River Biologics group offers over 50 years of experience and proven regulatory expertise, addressing challenging projects for biotechnology and pharmaceutical companies worldwide.
We provide a variety of services, including contamination and impurity testing, protein characterization, bioassays, viral clearance studies, stability, and lot release programs.
We support clients throughout the biologic development cycle, from establishment and characterization of cell banks through preclinical and clinical studies to marketed products.
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.
We also provide a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities.
We utilize this broad portfolio of products and services to enable our clients to create a more flexible drug development model, reducing their costs, enhancing their productivity, and increasing speed to market.
Our Mission:
We are passionate about our role in improving the quality of people's lives.
Our mission, excellent science, and strong sense of purpose guide us in all that we do.
We approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe.