Senior QC Analytical Scientist, Bioassay
Blackfield Associates is partnered with a leading Biotechnology company based in Cheshire seeking diverse leader with good understanding of the development of a Quality culture whilst under stringent timelines that will include ever-changing circumstances and a dynamic environment.
The position will be responsible for maintaining, developing and improving the company's QMS to GMP compliance whilst working toward securing the company's MHRA licence.
This person will lead, recruit, develop and train existing/new staff in a fluid environment and act as a key opinion leader for the Deeside facility.
The post-holder will establish ‘new-to-business objectives' and be accountable for keeping the company in a ready and steady state throughout change as milestones are achieved.
Key responsibilities within the position will be to (Not limited to):
- Be the lead subject matter expert for Quality & Compliance related issues.
- Provide line management for, shape and run Quality Assurance and Quality Control teams.
- Review and evaluate batch records and authorise batch disposition (Annex 16).
- Ensure that testing is carried out according to analytical control procedures and EU Pharmacopoeia.
- Approve process deviations/laboratory investigations ensuring compliance to Good Manufacturing Practice and internal business procedures.
- Monitor and trend the nature, extent and frequency of complaints.
- Co-ordinate internal and external auditing programmes.
- Establish and evolve a strategy that will support the site growth with effective resource including workload, project assignment and cross-functional collaboration.
- Build and maintain relationships with external vendors, customers and collaborators.
- Liaise directly with Regulatory Authorities and lead the preparation and management of inspections.
- Support site validation activities ensuring the regulatory requirements are met.
- Monitor performance of suppliers, contract laboratories and contract manufacturing partners.
- Establish relationships with the Leadership group to support the short to long-term strategy of the entire business and to mould the Quality department into an effective and well-resourced business unit.
- Continually improve, refine and execute programmes to build and maintain Quality culture within the organisation.
The ideal candidate for this opportunity will:
- Degree qualified, ideally PHD and/ or MBA within a relevant Scientific or Quality Management field.
- Industry experience of 10 years in a Quality role and at least 5 years in a leadership position (department head).
- Experience of running a small to medium-sized Pharmaceutical/ Biotechnology business in a ‘steady state'.
- Minimum of 10 years Quality experience within manufacturing, ideally Biologicals or Antibody Drug Conjugates.
- Well-developed understanding of Quality & Compliance strategies, tactics, processes and development.
- Experience of change/transformation management in a growing, compliant organisation.
- Thorough understanding of GMP guidelines and Health Authority regulations (MHRA).
- Has acted as point of contact and led meetings/audits/inspections with Health Authorities.
- Line management experience of technical departments including Quality Assurance and Quality Control.
- Ability to act as a Qualified Person under the Permanent Provisions of 2001/83/EC.
- Previous experience of securing an MHRA licence for a Brown-field or Green-field site will be advantageous.
STR Limited is acting as an Employment Agency in relation to this vacancy.
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