Quality Manager- Life Sciences

Location: Stevenage

Our Client is a leading engineering and maintenance provider, supporting customers across the chemical & petrochemical, nuclear, oil & gas, pharmaceuticals & biopharma, power & energy, utilities, renewables and food & beverage markets. We enhance the efficiency of assets, ensuring a high level of availability and reducing maintenance costs.

We have extensive experience in offshore and onshore facilities; specialising in asset management services throughout all life cycle phases from consulting, engineering, manufacturing, assembly, operations, maintenance, and decommissioning. This commitment is delivered by an experienced and highly competent workforce of over 4,500 employees operating from 14 offices in strategic industrial hubs, upholding the highest standards of safety, compliance and quality.

The Quality Manager will be responsible for the oversight and execution of quality related activities through all stages of project. Responsibilities will include leading the development and implementation of policies, procedures and protocols to control GMP activities, implementation of GMP standards and on-going compliance initiatives and regulations. The role will obviously involve interaction with our Client, internal stakeholders and external suppliers.

DUTIES & RESPONSIBILITIES:

• Serve as GMP Quality for assigned programs
• Develop and follow procedures for the oversight of quality aspects of pharmaceutical development in an outsourcing environment, including the quality aspects of process and formulation development, manufacturing, analytical testing, packaging areas
• Perform quality activities such as:
  • Validation protocols,
  • Report review and approval,
  • Specification review and approval
  • Batch record review, approval and release to ensure timely delivery of finished products to support the clinical development plan as well as commercial sales plan
• Oversee supplier quality management activities for assigned suppliers, including;
  • Confirmation of compliance,
  • Management/conduct of quality audits and inspection readiness activities
  • Creation and management of site inspection test plans, non-conformance reports via company ACTIVE management system.
• Perform and participate in internal audits as assigned

EXPERIENCE & QUALIFICATIONS:

• Successful applicants must be able to demonstrate excellent quality experience as well as 3+ years of hands on QA/QMS experience ideally within a manufacturing or highly regulated environment
• A demonstrated ability to develop and implement procedures
• Demonstrated audit conduct and management experience
• Fluent English communications skills (written & spoken)
• CQI membership(preferable)