Senior Quality Assurance Manager

Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growthI am working with a Clinical stage biotech company who're a market leader in autoimmune diseases and we're on the hunt for a Senior QA Manager to join a well established QA function.Responsibilities:Manage QA operations at a site level in accordance with Quality Agreements and GMP regulations.Serve as the QA representative on the Senior Leadership Team.Lead site and QA team adherence to local or corporate Quality Management Systems.Assist in developing the PQS, including implementing an eQMS where applicable.Develop new quality processes, policies, and data management practices, establishing and enforcing quality standards and metrics.Establish relevant Quality metrics and KPIs, monitoring trends, and assessing the effectiveness of quality management systems, reporting findings to SLT and Executive Team.Utilize quality metrics to minimize risks to patient safety, enhance compliance, ensure data integrity, and optimize business processes.Identify and communicate significant quality-related matters or risks affecting product quality, release, or regulatory compliance.Oversee complex QA activities to ensure compliance with GMP, GCP, HTA, and other regulatory requirements for cellular therapies and AT(I)MPs.Ensure procurement, testing, and importation of starting materials align with UK HTA requirements.Manage PQS elements related to cellular therapy manufacturing, including document control, quality risk management, training, validation, change control, audits, CAPA, vendor qualification, deviation reporting, batch record review, and complaint handling.Develop, review, and approve Quality and GxP documentation.Conduct risk assessments and investigations, providing coaching as needed.Approve equipment, materials, and services for site use.Conduct external audits as necessary.Provide input into strategic decisions impacting the QA department or organization.Organize and deliver QA training, including basic GMP training.Serve Serve as a subject matter expert on Quality processes as needed.Experience:At least 10 years of experience in a GMP manufacturing environment, primarily in QA or quality-related positions (preferably in small-scale operations such as ATMPs, clinical trials, or personalized patient products).Proven experience in providing QA support for the manufacturing of ATMPs.Demonstrated track record of successfully leading small teams of QA professionalsTechnical Requirements:Proficiency in offering scientifically sound, risk-based, and practical quality guidance to manufacturing and quality control operations.Substantial experience in drafting and evaluating GxP documents (such as SOPs,
qualification/validation
reports, and batch records) to ensure adherence to robust documentation practices, data integrity, and essential GxP, quality, and regulatory standards.Strong familiarity with GMP principles pertinent to sterile production, cleanroom environments, aseptic techniques, and sanitary standards for sterile products.Extensive knowledge of regulatory frameworks and processes specific to the manufacturing and/or testing of cell therapy products and/or ATMPs.Track record of developing metrics and leveraging them to showcase the effectiveness of the PQS, enhance compliance, and mitigate risks.Proficient comprehension of HTA requirements concerning Tissues and Cells.Educational RequirementsUniversity degree in a biological science, chemistry or equivalentWe offer a competitive salary package commensurate with experience, along with comprehensive benefits including medical, dental, and vision coverage, retirement plans, and opportunities for professional growth within a rapidly evolving field.Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI. We strive to create a welcoming and inclusive environment for all employees.Send me alerts about jobs like this.Please enter your email address to continue setting up an email alert for similar jobs to this one. By entering your email address and clicking apply you will sign up to Jobs4 and agree to our terms and conditions .
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