Summary
Center for Breakthrough Medicines is seeking a quality expert to support the organization by establishing quality systems, drive growth, and ensure quality. The Quality Assurance Manager will help build scalable QA systems as the organization continues to grow. The role will be responsible for the overall management of the quality system within the organization and oversees all quality viral vector manufacturing activities and operations including oversight of the QA vector team and technical staff. This role also supports Manufacturing Operations, providing oversight, strategic thinking, and results focus to reliably meet and/or exceed the site’s production targets while achieving high levels of quality. This position requires an individual capable of partnering across the organization to manage a fast-paced production environment and deliver exceptional service to our clients. It also ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines.
Responsibilities
· Ensure that the quality and compliance are integrated into long term strategies and day to day operations of the Quality Assurance (QA) department.
· Lead the QA manufacturing operations team and ensure that compliance objectives are maintained in the context of overall organizational needs and objectives with oversight of QA Compliance, Document Control, and Training, and other functions assigned to QA across viral vector manufacturing.
· Act as quality representative on core team to support client programs
· Lead the Company efforts to remain “inspection ready” and represent QA during regulatory inspections and client audits.
· Interpret industry regulations and guidance documents for the creation and implementation of quality standards, policies, and site procedures.
· Provide direction for the review of compliance procedures, Standard Operating Procedures, master batch records, specifications, validation master plans, validation protocols, and all other GxP documentation.
· Oversee the review and approval of GMP impact changes to processes, product specifications equipment and facilities, including oversight of the risk assessment/management process.
· Provide direction for the review of all physical plant and equipment layouts and specifications to ensure compliance with internal and regulatory requirements.
· Support the internal and external audit programs to ensure appropriate GMP raw material and service suppliers are selected and maintained and that critical internal GMP systems are operated in a compliant manner.
· Establish objectives and schedule tasks and resources efficiently.
· Demonstrate strong written communication skills to provide concise and clear documentation.
· Partner with other business units or departments in support of continuous improvement initiatives.
· Provide Quality System based leadership to ensure that our systems support our quality mission and ensure quality products are produced for contract manufacturing clients.
· Lead the QA function and evaluate opportunities for continuous improvements.
· Lead the effort of tracking and communicating quality improvement initiatives throughout the organization and promote a working culture in the organization that is quality based.
· Communicate Quality System performance to Senior Management on a regular basis and lead efforts to remediate compliance performance as required.
· Manage product complaints, adverse events, and any market action requirements from a quality assurance point of view.
· Manage the compliance function to ensure deviations, including reports associated with environmental monitoring, water, and cleaning excursions are effectively managed and decisions taken support the overall quality objectives, exercising direct supervision of critical compliance issues.
· Perform other related duties as assigned
Qualifications
· Minimum 5 years’ experience in the Contract Research Organization (CRO), or biopharmaceutical industry within a GMP environment.
· 5-10 years Quality Professional in Pharmaceutical industry
· Minimum 5 years direct people management
· Possesses front-line practical experience and real time decision making with cross functional support
· Proficient in Verbal and Written communication skills
· Proficient in Microsoft Office (Excel, Word, Outlook) Excellent problem solving, risk analysis and negotiation skills
· Ability to review data and effectively identify and trends or key issues
· Ability to manage multiple projects simultaneously ensuring on time execution of deliverables
