Global Quality GVP Manager at Sobi

Basel, Basel-City, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

08 Apr, 26

Salary

0.0

Posted On

08 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Oversight, Pharmacovigilance, Audit Management, Quality Assurance, GVP Regulations, Interpersonal Skills, Multitasking, Proactive, Resilience, Collaboration, Life Sciences, QA Systems

Industry

Pharmaceutical Manufacturing

Description

Company Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases. As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo. We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development. Job Description In this pivotal position, you will ensure quality oversight and assurance across our global pharmacovigilance (PV) activities. You will guide and support both global and local PV initiatives, contribute to the development of audit strategies and plans, and act as a key partner in cross-functional projects. Your work will involve collaborating with stakeholders across the Sobi organization, supporting the qualification of service providers, and representing quality assurance during inspections and audits. Based at our Global Headquarters in Stockholm or our hub in Basel, you will report directly to the Senior Director, Head of GCP/GVP Global Quality. This position is based at our Global Headquarters in Stockholm, Sweden or Global hub in Basel, Switzerland, reporting directly to Sr Director, Head of GCP/GVP Global Quality GCP/GVP Key Responsibilities Ensuring quality oversight and quality assurance activities related to GVP area Guide and support from a quality perspective the global and local, as applicable, PV activities within Sobi Contribute to the development of the audit strategy& program and plans related to the GVP area-PV processes, vendors, Partners and affiliates Act as a GVP Audit Program Owner when delegated by Global Quality GCP/GVP Head Support the Global GPV organization in their PV QMS related activities and local ones, as applicable Perform and coordinate PV audits internally and externally and act whenever needed as delegated by Global Quality GCP/GVP Head Support and collaborate with GPV organization and the safety interfaces such as Medical Affairs, Regulatory Affairs and Affiliates, as applicable Ensure qualification of global and local ESP, as applicable in GVP regulated area per Sobi procedures Act as QA representative in PV Inspections and different initiatives or projects as needed Qualifications About you You are a structured, results-oriented professional who thrives in a dynamic, fast-paced environment. Your strong interpersonal skills and flexible, communicative approach make you a valued collaborator. You are proactive, resilient under pressure, and adept at multitasking. Most importantly, you are passionate about making a positive impact for patients and are eager to contribute to Sobi’s mission and values. Key Qualifications University degree in Life Sciences or related field Minimum 5 years’ experience in the pharmaceutical industry with GVP responsibilities Proven experience in audit management and/or quality assurance Strong knowledge of EU/US/Rest of World GVP regulations Experience with QA systems and auditing is highly valued Here at Sobi we live by our core values: Care, Ambition, Urgency, Ownership and Partnership! Additional Information How to apply We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English. Why Join Us? Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team: Emphasis on work/life balance Collaborative and team-oriented environment Opportunities for professional growth Diversity and Inclusion Competitive compensation for your work Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. Sobi Location: Switzerland

Responsibilities

Ensure quality oversight and assurance across global pharmacovigilance activities. Collaborate with stakeholders and support the qualification of service providers.