Pace Analytical Life Sciences – Bio Concept 13 Industrial Way Salem, NH 03079
Bio-Concept Laboratories, a Pace Analytical Life Sciences Laboratory, located in Salem. New Hampshire is a Contract Research Organization offering a full range of pharmaceutical product development services from pre-formulation, through aseptic manufacturing and stability, supporting Phase I, II, & III clinical studies.
We are actively seeking a candidate to lead our Quality Assurance (QA) team within our Salem, New Hampshire location. This is an exciting opportunity for a seasoned QA leader, who has worked in a clinical trial material/sterile fill-finish pharmaceutical manufacturing and laboratory environment, The ideal candidate is one who thrives working in a highly dynamic, team- oriented environment sharing the common goal of providing our clients with the materials and information they need to improve the safety and effectiveness of pharmaceutical and biopharmaceutical products.
The Director of QA is responsible for day to day operations within the QA department and functions as the subject matter expert on the Quality Management System (QMS). The Director will maintain and improve the QMS through continuous development, implementation and maintenance of quality standards, policies and procedures incorporating flexibility while ensuring rigorous regulatory compliance. Additionally, the Director will be responsible for establishing a scalable quality system to support the future enhancement of cGMP manufacturing capabilities.
Business activities vary from research and development, to formulation / process development, to clinical trial material manufacturing of pharmaceutical and biopharmaceutical products.
The ideal candidate is self-guided and highly motivated, demonstrating a strong sense of self-initiative and flexibility, a desire to collaborate with other senior staff throughout the organization, ability to provide quality and technical guidance to all departments and an interest in continuing to acquire new knowledge and skills. Preferred qualifications include QA experience in clinical trial material/sterile fill-finish pharmaceutical manufacturing and laboratory environments.
• Directs the development and implementation of Quality Management System goals, objectives, policies, procedures and work standards throughout the facility.
• Monitor, communicate, educate and administer Quality Management System essentials
• Timely review and approval of batch records, quality agreements, vendor qualification documents and analytical/microbiology records.
• Initiate, review and approve investigations, risk assessments, deviations, CAPA, change records, etc. and recommend corrective actions/CAPAs related to cGMP and QMS issues
• Proactively identify compliance issues/risks, within the organization
• Contribute effectively to the accomplishment of team or work unit goals, objectives and activities.
• Establish and maintain effective working relationships with the other departments
• Building the QA team to support the company’s growth
• Manage all customer, supplier or regulatory audits.
• Function as the key Quality representative for customer questions regarding compliance or procedure.
• Develop and maintain computer skills related to work performed, including familiarity with manufacturing and laboratory computer applications (e.g., CMS/BMS/EMS, LIMS, Waters Empower Chromatography System).
• Assure all work performed is compliant with Pace Analytical Life Sciences SOPs and GMP requirements.
• Become familiar and regularly updated with quality and regulatory policies associated with the technical area.
• Minimum ten years of Quality Assurance Management experience at a managerial level, preferably in FDA regulated, clinical trial material/sterile fill-finish pharmaceutical manufacturing and laboratory environment
• Ability to prioritize and handle multiple activities on a daily basis yet flexible and responsive to frequently shifting priorities
• Demonstrated ability to accomplish stated goals through others even though they may not report directly to you
• Strong sense of ethics and honesty
• Expert knowledge of GMP and FDA regulatory requirements applicable to clinical trial and/or sterile product manufacturing
• Demonstrated ability to integrate into a team environment with a positive attitude
• Strong interpersonal skills
• Bachelor’s Degree in Chemistry or closely related field preferable environment
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.
Work is performed in a lab and office setting. Work is subject to chemicals, fumes, gasses, noxious odors and related items in a lab setting.
OFCCP Statement Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, and individuals with disabilities, sexual orientation, or gender identity.