Responsible Person Austria, Senior Manager GDP Operational Quality

Job Description

General Summary:

The GDP Operational Quality Senior Manager will act as Responsible Person (RP, "Fachkundige Person") for Vertex Pharmaceuticals Austria, keeping oversight of the local distribution network, ensuring ongoing maintenance of the WDA, leading regulatory inspections, and supporting International Quality in wider regional or global projects.

This position holder will also support Vertex Pharmaceuticals Germany and act as Responsible Person deputy, assuming the key responsibilities as defined in local legislation in the absence of the Responsible Person of Vertex Germany.

This is a hybrid role based in Austria.

Key Duties and Responsibilities:

• Perform RP duties as per GDP guidelines.
• Ensure that a Quality Management System is implemented and maintained.
• Ensure that initial and continuous training programs are implemented and maintained.
• Coordinate and promptly perform any recall operations for the products. Take an active part in annual mock recalls.
• Ensure that relevant customer complaints are dealt with effectively.
• Ensure that suppliers and customers are approved.
• Ensure that self-inspections are performed at appropriate, regular intervals following a prearranged program and necessary corrective measures are put in place.
• Decide on the final disposition of returned, recalled or falsified products. Approve any returns to stock.
• Remain continuously contactable and available to attend the site as required
• Ensure the WDA accurately reflects the current organisation, performing variations where necessary.
• Review and approve appropriate GxP documentation including procedures, work instructions, records and Quality Agreements.
• Prepare and lead Quality management reviews.
• Participate in quality risk management.
• Participate in quality escalation meetings, providing input and where required, notifying local Health authorities of Quality Defects.
• Manage and approve change controls, deviations and CAPA where required.
• Prepare and host GDP inspections from the local Health Authority (providing front room inspection support and leading post inspection follow-up with responses and CAPAs)
• Monitor, assess impact and communicate Regulatory Intelligence information.
• Maintain knowledge of EU Good Distribution Practice, applicable Good Manufacturing Practice and local GDP/GMP guidance.
• Act as QA single point of contact with local Health Authorities, ensuring relevant stakeholder involvement and timely correspondence.
• Manage internal audits and support external audit scheduling, scope, and other qualification activities as needed.
• Support Vertex Market Quality team in establishing and maintaining corporate quality objectives.
• In liaison with the MAH, monitor the products inventory and communicate to local authorities any potential supply shortage, as required.
• Ensure that any additional requirements imposed by national law are adhered to.

Knowledge and Skills:

• Broad and deep health regulatory agency knowledge and experience across multiple GDP/GMP with current knowledge of industry trends and best practices for efficiency, compliance and effectiveness
• 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
• Attention to detail
• Root Cause Analysis tools/methodology
• Critical thinking / Problem solving / decision making
• Sense of urgency - ability to act quickly/escalation process/transparency
• Excellent communication skills and a proven track record influencing/building/promoting a culture of Quality and Excellence
• Fluency in German and English

Education and Experience:

• Relevant degree
• Eligible to act as a Responsible Person in Austria and deputy Responsible Person in Germany

#LI-SM1

#LI-hybrid

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

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 [email protected]