Quality Manager, Responsible Person

SERB Pharmaceuticals

  • Weybridge, Surrey
  • Permanent
  • Full-time
  • 1 month ago
Come and Save Lives with Us!SERB is a fast-growing specialty pharmaceutical company that equips healthcare providers worldwide with life-saving medicines for patients facing rare conditions and emergencies.For over 30 years we have consistently provided emergency medicines, medical countermeasures, and the world's leading portfolio of antidotes.Today SERB has over 500 employees in 18 countries and group revenue in excess of €400m. With a strong presence in the US, Europe, and the Middle East, along with a global network of trusted distribution partners, we make a broad range of essential medicines available in over 100 countries.Having the right culture is as important to us as having the right portfolio. We are guided by our four values:
  • We make patients our priority
  • We act with accountability and integrity
  • We work together as one team
  • We look for better ways forward
By expanding our reach through selective acquisitions and entering new markets, we're not just supplying medicine; we're improving the standard of care for more patients around the world.Broad FunctionThe Quality Manager / Responsible Person (RP) is accountable for ensuring the company's compliance with GMP, GDP, and UK regulatory requirements related to the manufacturing, importation, and distribution of medicinal products. As a designated RP on company Wholesale Distribution Authorisations (WDA(H)), you will oversee all activities impacting product quality and compliance across the supply chain. The job holder will be responsible for GMP compliance, providing QA leadership for changes and issues that arise within the external GMP network.As the Quality Manager, RP your responsibilities will include:GMP & Quality Management:
  • Ensure the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) at Weybridge.
  • Oversee all sub-systems of the QMS including, but not limited to: deviation management, change control, complaints and CAPA.
  • Work with the site team to ensure that QMS metrics are maintained per company targets.
  • Provides expert GMP QA oversight to the company's operations and external network.
  • Key quality contact for contract manufacturing organisations (CMOs) and suppliers within the external network. Ensuring that they are held accountable to GXP expectations and commitments.
  • Ensure that CMOs, suppliers and service providers are qualified per company procedures.
  • Ensure that GXP changes internally and within the external network are managed appropriately using prospective, formal change management.
  • Coordinate the company's response to deviations and non-conformances both internally within the external network. Ensure that the company's response (risk assessment, reporting, CAPA plan development) is both timely and comprehensive with diligent communication to stake holders.
  • Diligent oversight of CAPA plans and commitments ensuring that timelines are met and CAPA implemented in full internally and externally.
  • Oversee the control of internal documentation supporting manufactures i.e. master specifications, formulation and methods, protocols and reports and the contractor documentation and maintaining the product specification files.
  • Ensure that SERB's external auditing schedule and processes adequately cover the GXP service providers within the external network. Lead GXP audits and oversee remediation and follow-up.
  • Oversee the stability programme ensuring compliant coverage of the company's licensed and unlicensed product portfolio.
  • Lead local quality reviews and contribute to group level management review forums.
  • Provide training and education in GMP compliance for staff and management in the UK and beyond as necessary.
  • Responsible Person Duties & GDP Oversight:
  • Act as the MHRA-named Responsible Person, ensuring compliance with GDP under the WDA(H) for the Weybridge site and other UK sites as assigned.
  • Ensure products are procured, stored, transported, and handled in compliance with the Marketing Authorisation and GDP.
  • Release duties (if applicable) in accordance with Annex 16 and ensure no batch is released unless it meets quality and regulatory standards.
  • Ensure all suppliers and customers are approved and licensed accordingly.
  • Maintain oversight of temperature-controlled storage, distribution, and supply chain security.
  • Coordinate the RP team for GDP compliance at the company's UK sites holding WDA(H)'s.
  • Ensure that UK sites holding WDA(H)'s are inspection ready at all times.
General
  • Develop and implement GMP/GDP training and education programmes for staff as necessary for their roles. GDP training must be provided to staff at other UK sites and beyond as necessary for compliance.
  • Lead maintenance the Controlled Drug licence for Weybridge as per UK Home Office guidance.
  • Promote a culture of quality and continuous improvement across the organisation.
  • Carry out other reasonable tasks as required by the Line Manager.
  • Ensuring that all interactions and engagements are carried out in accordance with Company values.
To be successful in this role, you should demonstrate:
  • Life sciences degree (e.g. Pharmacy, Chemistry, Biology, Pharmaceutical Sciences).
  • Minimum of 5 years' experience in GMP and GDP environments, ideally in both manufacturing and distribution of medicinal products.
  • Eligible to act as a Responsible Person under MHRA guidelines (as per GDP Guide, Chapter 2).
  • In-depth knowledge of UK/EU GMP and GDP regulations (including Human Medicines Regulations 2012).
  • Experience in MHRA inspections and regulatory authority engagement.
  • Experience in auditing GMP and GDP service providers.
  • Strong knowledge of GMP, GDP, and UK/EU regulatory requirements.
  • Excellent problem-solving, organisational, and communication skills.
  • Strong leadership and decision-making ability.
  • Detail-oriented with a strong sense of accountability.
  • Ability to build effective relationships with cross-functional teams, suppliers, and regulators.
Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.

SERB Pharmaceuticals