QA Manager, Remote
£45k – £60k + Up to 20% annual bonus + private healthcare etc.
Quality Team Manager being a part of an innovative Biotech oriented organisation that is a fast-paced company which strives to supervise and support external service at the highest level, and provide its employees with a platform to learn and grow.
This role involve managing an external network of manufacturing and testing sites that provide full spectrum biopharmaceutical manufacturing services in the production of bulk Active Pharmaceutical Ingredient (DP) and Drug Product (DS).
- Create and enhance collaborative and trusting relationships with external manufacturing sites and internal SMEs and establish effective communication.
- Oversee and provide the leadership to the Quality External Manufacturing team, responsible for the execution of all related External Manufacturing Quality assurance tasks applicable.
- Responsible for Quality Assurance oversight of the external manufacturing operations and related projects to ensure the corresponding GMP compliance in every phase according to regulatory expectations. This includes:
- Provide guidance and supporting external manufacturing with Product Disposition;
- GMP Document Review;
- Supervise the changes that affect external manufacturing including but not limited to: facility, equipment, raw materials;
- Support, review and approve External Investigations and ensure issues are tracked within company QMS system;
- Ensure escalation of substantial issues;
- Ensure External manufacturing risks are adequality addressed within site Risk Management Processes.
- Managing external auditing program
- Ensuring that Quality Agreement are in place and up to date.
- Review, analyse and approve the change controls, unplanned deviations, product release test results, microbial control plans, lab investigation reports, and manage OOS investigation.
- Ensure provision of shop floor oversight of manufacturing at external sites at a time of contracted product manufacturing as deemed necessary.
- Acting as a senior quality representative in project onboarding new product, new manufacturing sites.
- Providing guidance with respect to the GMP requirements relevant to the project stage in development and onboarding processes.
- Making sure that supervised team is prioritising related tasks according to their criticality ensuring critical pathway of the project is not affected;
- Management resources in support of multi-site manufacturing operations;
- Direct engagement with regulatory inspections including preparation, management & response development;
- Training of Quality personnel in the principles and application of cGMP pertaining to work that supports external cGMP manufacturing and lot disposition;
- Assessing required resources, hiring, coaching and mentoring professional Quality staff.
- Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all working practices meet the required Quality standards and are in accordance with the company’s values
- Representing Quality at the senior level as an active member of key project teams.
Education and Experience
- Life Science degree in Biology, Microbiology, Biochemistry, Pharmacy, Biotechnology or Chemistry (or equivalent) is preferred.
- Experience in dealing directly with both regulatory agency personnel as well as the CDMO provider representatives.
- Experience in operational GMP in a pharmaceutical manufacturing environment including batch disposition;
- Experience in working in a multidisciplinary environment and supplier relation management.
- At least 3 years of experience in Quality or Quality Assurance functions within the Pharmaceutical or Medical Device Industry is required.
- At least 3 years in supervisory experience.
- Experience dealing with applicable Health Authority inspections.
- Deep understanding of the regulatory/Quality responsibilities active pharmaceutical ingredient (DS) and drug product batch disposition.
- Subject Matter expertise in several elements of pharmaceutical manufacturing.
- Extensive organisational/personnel management capabilities..
- Ability to respond to common inquiries, regulatory agencies, or members of the business community.
- Ability to effectively present information to top management. public groups. and/or boards of directors.
- High tolerance for ambiguity in a complex environment. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to build partnerships both internally and externally. Ability to effectively interface with governmental and independent auditors.
- Demonstrates strong leadership competencies.
- Strong, motivated leader with the ability to direct, motivate and lead team members by example and from afar.
- Ability to think and act independently and strategically, whilst self-motivating and comfortable in a high profile and transparent role.
- Demonstrated negotiation and influencing skills.
- Commercially aware of the value of Quality.
- Strong financial awareness with budgeting ability
- Willing to travel within UK, EU and internationally for up to 15% of the time
Private healthcare etc.
Amazing holiday allowance
Join a friendly, collaborative team