Vertex Pharmaceuticals
GDP Operational Quality Senior Specialist, 12 month contract
Job Description
This is a hybrid role where you will be expected to be onsite 3 days per week and work from home 2 days per week.
You may be required to travel up to 10% of the time.
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:
The responsibilities of this position will include, but are not limited to, the following:
- 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) have been 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 and assist with risk mitigation plans as necessary.
- Support internal audit or external audit programs and inspection readiness activities as well as tracking post-inspection readiness.
- Support the lifecycle management of distribution partners engaging with cross functional teams.
- Support the status of distribution partners, vendor related plans, and ongoing gaps or risks for programmes.
- Support GDP operational quality in gathering relevant documentation for disposition on temperature excursions.
- Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions.
- Support recalls, mock recalls, and any other in-market activity.
- Support in New Product Launch activities to assess new territories distribution requirements and expectations.
- Have a strong knowledge of GMP and GDP regulations and requirements.
Experience, Skills and Qualifications:
- Bachelor’s degree in a scientific or allied health field (or equivalent degree) and work experience, , or relevant comparable background
- Knowledge of International GDP regulations; GMP and GVP regulations as a preference.
- Ability to learn new information and roll out to the wider audience to develop their knowledge.
- Ability to evaluate quality matters and make decisions utilizing risk-based approach
- Ability to collaborate cross-functionally across all levels of the 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 and resource management and prioritization, planning and organization skills
- Relationship Management skills- communication, influence, conflict management, ability to understand and translate customer needs
- Strategic thinking / forward thinking / planning
- Technical writing
- Knowledge of global GDP/GMP requirements governing oral drug products and knowledge of product manufacturing practices
#LI-SM2
#LI-Hybrid
Flex Designation:
Remote-Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. 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 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
