Description
Job Location: London, UK
Job Location Type: Hybrid
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
General Position Summary:
The Senior Quality Specialist is recognised as an expert internally in the principles and application of quality assurance, compliance. This role supports GDP operations for all distribution activities within the global distribution network; key stakeholders include Operations QA, International Supply Chain, demand planning, logistics, Geographic expansion, QMS/OMS QA, Vendor Management & AIM QA.
Key Responsibilities:
- As a QA SME, provide technical and strategic support to functional areas including other teams within the International region for change controls, deviations, qualification, and risk assessments.
- Lead and triage quality investigations (including deviations and complaints), ensuring they are fully documented with appropriate root cause and corrective and preventative actions (CAPA) identified and addressed.
- Write and maintain Quality Agreements between Distribution partners and Vertex as needed.
- Ensure GDP and quality compliance by identifying and implementing areas for continuous improvement.
- Maintain Quality Metrics within the GDP operational Quality team and distribution partners.
- Identify and communicate risks; assist with risk mitigation plans as necessary.
- Support internal audit or external audit programs; inspection readiness activities as well as tracking post-inspection readiness.
- Support lifecycle management of distribution partners engaging with cross-functional teams; support status of distribution partners vendor-related plans; ongoing gaps or risks for programmes.
- Support GDP operational quality in gathering relevant documentation for disposition on temperature excursions.
- Collaborate with internal/external business partners to resolve quality issues to ensure compliant solutions.
- Support recalls, mock recalls, any other in-market activity.
- Support New Product Launch activities to assess new territories' distribution requirements/expectations.
Experience, Skills And Qualifications:
- Bachelor’s degree in a scientific or allied health field (or equivalent degree) with work experience or relevant comparable background.
- Knowledge of International GDP regulations; GMP/GVP regulations preferred.
- Ability to learn new information/roll out to wider audience to develop their knowledge.
- Ability to evaluate quality matters/make decisions utilizing risk-based approach.
- Ability to collaborate cross-functionally across all levels of organization.
- Ability to drive results/adaptability/flexibility.
- Analytical thinking/data analysis/attention to detail/change management/continuous process improvement/critical thinking/problem-solving decision-making/project management-time/resource management/prioritization/planning organization skills relationship management skills communication/influence/conflict management ability understand translate customer needs strategic thinking forward-thinking planning technical writing knowledge global GDP/GMP requirements governing oral drug products knowledge product manufacturing practices.
Flex Designation: Remote Eligible
Flex Eligibility Status:
In this Hybrid Eligible role you can choose designation as:
Hybrid: work remotely up two days per week;
On-Site: work five days per week on-site with ad hoc flexibility.
Note:
The Flex status for this position is subject Vertex’s Policy on Flex @ Vertex Program may be changed at any time.
Company Information:
Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed equal employment opportunity non-discrimination all employees qualified applicants without regard person's race color sex gender identity expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status characteristic protected under applicable law.Vertex an E Verify Employer United States.Vertex will make reasonable accommodations qualified individuals known disabilities accordance applicable law.Any applicant requiring accommodation connection hiring process/or perform essential functions position which applicant applied should make request recruiter hiring manager contact Talent Acquisition at Lifelancer (https://lifelancer.com) talent-hiring platform Life Sciences Pharma IT.The platform connects talent opportunities pharma biotech health sciences healthtech IT domains.For more details find similar roles please check below Lifelancer link https://lifelancer.com/jobs/view/f03985f1dcfb08d209ba296200ea9842
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