Senior Quality Specialist

Talent Works; London; Hybrid; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Senior Quality Specialist to join their dynamic team. This contract role focuses on supporting Market Quality and ensuring compliance within the global distribution network. You will play a crucial role in managing quality assurance processes, collaborating with various stakeholders, and ensuring adherence to GDP regulations. The ideal candidate will possess a strong background in life sciences, excellent organizational skills, and a proactive approach to problem-solving. This is a fantastic opportunity to contribute to impactful projects in the biotechnology sector while working in a hybrid setting that balances flexibility and collaboration.

Qualifications

• Bachelor's degree in life sciences or technical discipline required.
• Experience with compliance issues and deviations handling.
• Proficiency in digital tools to enhance QA performance.

Responsibilities

• Support QMS processes including deviations and CAPA management.
• Prepare QMS data reports and support audits.
• Collaborate with stakeholders for quality assurance activities.

Skills

Compliance Handling

Organizational Skills

Critical Thinking

Communication Skills

Digital Tools Utilization

Collaboration

Process Improvement

Education

Bachelor's Degree in Life Sciences

Degree in Pharmacy or Related Field

Tools

Veeva

Microsoft Office

Job description

Company Name:

Vertex Pharmaceuticals

Type of Role:

Contract position, Inside IR35

Contract length:

12 months

Location:

Hybrid (3 days on site in Paddington)

Department:

Market Quality

Looking for opportunities with purpose, impact, and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline rapidly, they are strengthening their reputation for creating transformative medicines for people with serious diseases.

The Senior Quality Specialist (Contractor) role supports Market Quality and is recognized as an internal expert in quality assurance and compliance principles and application.

This role supports GDP operations for all distribution activities within the global distribution network; key stakeholders include Operations QA, International Supply Chain, logistics, Geographic expansion (particularly LATAM market quality & EEMEA), QMS QA, Vendor Management, and AIM QA.

Key Responsibilities:

1. Take ownership and support QMS processes (Deviations, CAPA & Change Controls) including Root Cause Analysis, Risk Assessment, Action completion, and timely closure of records.
2. Support the intake, triage, and logging of deviations & distribution complaints into the Veeva electronic Quality Management System (VeeQMS).
3. Liaise with stakeholders to gather information for investigations and root cause analysis, ensuring timely tracking and closure.
4. Prepare materials for distributor sites to monitor deviation performance, cascade information, and follow up on outstanding items.
5. Support LATAM & EEMEA MQ teams with distributor meetings, KPI monitoring, action follow-ups, and creating action lists.
6. Manage Veeva actions and follow ups to close actions on time.
7. Assist with SOP processing through Veeva.
8. Follow up on actions related to distributor gap assessments.
9. Raise risks/issues with timelines and seek support for resolutions.
10. Support change control records and quality actions.
11. Prepare QMS data reports/KPIs for various governance meetings and inspections.
12. Assist in creating and updating Quality Agreements with Vertex Affiliates and external vendors, including documentation management.
13. File quality records per Vertex records retention policies.
14. Support audit programs, inspection readiness, and post-inspection activities.
15. Gather documentation for GDP operational quality related to temperature excursions.
16. Support Self-Inspections and closure of deficiencies.
17. Manage the International Quality inbox for QA queries.
18. Assist the Responsible Person with license-related responsibilities.

Minimum qualifications / SKILLS:

• Bachelor's Degree in life sciences or technical discipline.
• Experience handling compliance issues from deviations or product defects.
• Strong organizational, time management, and flexibility skills.
• Ability to prioritize, work within deadlines, and demonstrate decisiveness.
• Proactive with critical thinking skills.
• Excellent communication skills with high attention to detail.
• Proficient with digital tools and systems to enhance QA performance.
• Knowledge of International GDP regulations.
• Ability to collaborate across all organizational levels.
• Results-driven mindset.
• Continuous Process improvement mindset.

Preferred Qualifications:

• Degree in pharmacy, chemistry, medicine, biology, or related life sciences.
• Experience with GDP & GMP work, or similar background.
• Experience with electronic QMS tools like Veeva.
• Knowledge of EU GxP regulations and standards.
• Fluency in English.
• Resident in UK.
• Proficiency in Microsoft Office applications.

Vertex partners with Talent Works to manage their international temporary roles. Successful applicants will be employed by Talent Works for this temporary assignment at Vertex.