Quality Assurance & Pharmacovigilance Partner (M/W/D)

1-5 years

Not Disclosed

Grenzach

10 May 27, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About the Job: Quality Assurance & Pharmacovigilance Partner

Responsibilities:

Implement, maintain, and continuously improve an efficient and harmonized Quality Management System (QMS) to ensure compliance with GCP, GDP, GMP, GVP at the Grenzach site.
Serve as Process Owner for various areas including Trainings Management, Document Management, Deviation Management, Change Management, Risk Management, and Vendor Management.
Contribute to the strategic direction of the newly created Affiliate Quality department within the framework of the company's strategy and regulatory requirements.
Provide central Quality Oversight (QA role) for the Regulatory and Pharmacovigilance (RPAG) team, ensuring end-to-end GxP compliance within the Affiliate.
Drive efficiency improvements of the QMS through continuous enhancements.
Manage, conduct, and follow-up on regulatory inspections in the GxP area and internal audits.
Lead projects and collaborate cross-functionally with GxP employees in Grenzach, global units, or other affiliates.
Act as the local single-point of contact and "Quality ambassador" for all quality-related matters at the Grenzach site.
Assume responsibilities of the Local Quality Responsible (LQR) function in the respective area.

Qualifications:

Bachelor's degree in a scientific discipline (preferably Pharmacy, Biotechnology, Chemistry, Food Technology) or equivalent, with specific experience in the pharmaceutical industry.
Profound knowledge of Quality Management Systems (GCP, GDP, GMP, GVP) and relevant regulations (e.g., EU-GMP/GDP guidelines, AMG, IVDR, CTR, MPG, MDR, ICH).
Extensive experience in project management (including Lean and Six Sigma) and cross-functional project coordination.
Strong audit and inspection experience.
Ability to use VACC principles for stakeholder alignment and coaching.
Entrepreneurial mindset with departmental cross-functional system thinking.
Self-driven with excellent communication skills and stakeholder management abilities.
Analytical, future-oriented, and pragmatic thinker with a risk-based decision-making approach.
Empathetic team player who collaborates effectively with diverse personalities.
Native-level German proficiency and C2-level English proficiency.

Application Process:

CV only - simply upload your resume and apply.

About Roche:

Roche fosters diversity, equity, and inclusion, believing that individuality and inclusion are essential for understanding varied healthcare needs. Join Roche, where every voice matters.

Contact Information:

For inquiries, please contact the Talent Acquisition Team at germany.talent_acquisition@roche.com.

Who We Are:

At Roche, over 100,000 people across 100 countries are pushing back the frontiers of healthcare. We are one of the world’s leading research-focused healthcare groups, driven by innovation, curiosity, and diversity. Roche Pharma AG at Grenzach-Wyhlen is a central hub for technical quality control in Europe, coordinating clinical research, marketing, and sales activities for the German market. Join our motivated team and enjoy numerous opportunities for personal development, flexible work hours, attractive compensation packages, and family assistance programs.

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Quality Assurance & Pharmacovigilance Partner (M/W/D)

Job Description

About the Job: Quality Assurance & Pharmacovigilance Partner

About Roche:

Contact Information:

Who We Are:

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