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Responsible/Designated Person UK, Senior Manager

Semma Therapeutics

Semma Therapeutics

Design
Paddington, London W2, UK
Posted on Friday, February 9, 2024

Job Description

General Summary:

The Responsible/Designated Person (Senior Manager), GDP Operations Quality, United Kingdom Role is responsible for ensuring the quality system is in place meeting the requirements of GDP and act as both Responsible Person (RP) on the Wholesale Distribution Authorisation (WDA) and Designated Person on the Active Substance Registration (ASR) held by Vertex Pharmaceuticals (Europe) Limited. (Vertex UK). Responsible Person UK role works with International QA Management team supporting continuous improvement initiatives and projects. In addition, this role helps to establish an appropriate QMS to support any aspects of the GMPs required for supply of ATMP in the United Kingdom and acts as the commercial quality contact ensuring local compliance to the MAH and GMP requirements.

Key Duties and Responsibilities:

  • Establish robust Quality Processes/Process Ownership for the distribution of Commercial Finished Goods and for the importation and distribution of active substances.
  • Responsible for maintaining the WDA & ASL Licenses and ensuring that variations and annual updates are made as required.
  • Provide QA oversight of all GDP activities in accordance with local requirements; ensure product procurement, storage and distribution are managed in accordance with GDP requirements.
  • Provide advice to senior management when required and must have personal knowledge of all the relevant GDP guidelines.
  • Proactively partner with other commercial departments to ensure quality aspects of new launches are properly handled. Set up effective collaborations with functional areas such as Regulatory, Supply Chain, local country manager.
  • Lead local affiliate Management Reviews.
  • Provide guidance and monitor quality issues related to products and GDP to resolution within the company and with external parties.
  • Raise and review documentation including change controls, deviations, CAPAs, SOPs and specifications relating to distribution activities. Provide training if required.
  • Responsible for conducting self-inspection as per schedule and audits of external suppliers.
  • Maintain, review and update Standard Operating Procedures for Quality Assurance and Distribution related activities ensuring compliance with GDP regulations.
  • Ensure Quality Technical Agreements are in place for all outsourced activities.
  • Approve any subcontracting that may impact GDP.
  • Contribute to defining standard GDP quality KPIs and to review quality indicators with recommendation for actions for improvement.
  • Host inspections of local Health Authorities.
  • Provide support to third party warehouse activities from a quality perspective.
  • Assess impact and communicate Regulatory Intelligence information
  • Escalate quality issues to senior management as per Vertex procedures.
  • Decide on the final disposition of returned, rejected, recalled or falsified medicines, including the approval of returns to saleable stock.
  • Keep appropriate records of delegated duties.
  • Support recalls, mock recalls and any other on-market activity.
  • Support in New Product Launch activities to assess new territories distribution requirements and expectations.Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.

Knowledge and Skills:

  • Expert knowledge of global GDP/GMP requirements and regulations.
  • Previous GDP auditing experience
  • Strong leadership skills with the ability to thrive in a high throughput environment.
  • Ability to evaluate quality matters and make decisions utilizing risk-based approach
  • Ability to collaborate cross functionally across all levels of the organization
  • Analytical thinking / Data Analysis/ Attention to detail

Education and Experience:

  • Degree in pharmacy, chemistry, medicine, biology or a related life science
  • Eligible to act as the Responsible Person in the United Kingdom.
  • Strong experience serving in a Quality role.
  • Fluency in English is required
  • Experience in presenting to Cross-functional Leadership teams.
  • Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.