QP Associate Director

Job title:

QP Associate Director

Company

Vertex Pharmaceuticals

Job description

Job DescriptionThe QP Associate Director role is responsible for ensuring licensed product is certified and released to market in compliance with commercial and clinical (IMP) manufacturing licenses in accordance with the requirements. Responsible for the implementation of the QP strategy within the organization. Acts as a primary point of contact for regulatory agencies in relation to batch certification activities and associated licenses.Key Duties and Responsibilities:Perform UK QP duties as per the GMP guidelines & Annex 16 to ensure that each individual batch of commercial or clinical product has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorisation (MA) and with Good Manufacturing Practice (GMP)

• Facilitate planning/ preparation/supporting/hosting Regulatory Inspections, providing front and backroom inspection support and Post inspection follow-up with responses and CAPAs
• Support external third-party audits as required.
• Participate in risk assessments as required.
• Review and approve Deviations and Planned Changes.
• Review and approve CAPAs and Effectiveness Checks.
• Provide quality and compliance guidance on critical and major quality matters
• Partners with critical contract manufacturers to resolve compliance issues in clinical and commercial supply chains, interfaces with customer/partner quality organisations, and negotiate third party contractor and supplier quality agreements
• Ensure that the QMS implemented and maintained, including the management of authorised activities and quality of records
• Negotiation with regulatory agencies on behalf of Vertex regarding matters relating to QP batch certification and license related matters
• Develop and maintain QP oversight procedures and processes to support the QP function
• Ensure Manufacturers Importation Authorisation (MIA) licenses accurately reflect the current organisation activities
• Monitor, assess impact and communicate Regulatory Intelligence information
• Prepare, negotiate, and approve Quality Agreements with Third Pary Manufacturers and Affiliate Partners
• Work with Vertex Product Complaints team to ensure that customer complaints are dealt with effectively
• Ensure that any additional requirements imposed on certain products by national law are adhered to
• Support product recalls and notification to Regulatory Authorities
• Responsible for issuance of QP declarations where required
• Representing Vertex QP organisation in this forum and shaping future regulatory requirements in QP space.

Knowledge and Skills Required:

• In-depth regulatory agency knowledge and experience in EU and UK GMP requirements with current knowledge of industry trends and best practices.
• In-depth and comprehensive understanding of QP/ batch certification concepts and principles expanding to QP integration with all facets of the organization/ industry sector.
• Work cross-functionally with all levels to foster exceptional collaboration.
• Proficiency in using Microsoft Office applications.
• 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.
• Good understanding of cell and gene therapy, oral solid dosage and sterile manufacturing.
• Ability to communicate effectively across all organizational levels.
• Ability to adjust presentation to audience and information real-time (adaptability in this setting).
• Ability to effectively influence others within technical area of expertise.

Education and Experience:

• Bachelor’s degree
• Eligible to act as a Qualified Person in accordance with the EU Guide to Good Manufacturing Practice in article 51 of Directive 2001/83/EC
• Previous experience acting as a QP and named on an MIA
• This role is Remote based position primarily focused on UK QP certification duties and we will be considering applications from across the UK & Northern Ireland.

Flex Designation: Remote-EligibleFlex Eligibility Status:In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.Company InformationVertex 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 [email protected]

Expected salary

Location

Paddington, West London

Job date

Wed, 24 Jul 2024 00:24:53 GMT

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