Associate Director, Pharmacovigilance Quality Operations - Switzerland
- Support CAPA development with cross-functional teams and serve as quality approver
- Track global CAPA progress and evaluate evidence for CAPA closure to ensure compliance with company and regulatory standards
- Support GPV process development and serve as quality approver for relevant controlled documents
- Ensure inspection readiness in the GPV, Regulatory, and Medical Information areas including SME training/preparation, inspection strategy, and back room/front room support activities; work with the R&D Audit and Inspection function to analyze risks and develop inspection readiness strategy, with particular focus on European agencies and regulators
- Coordinate quality inputs for PSMF and partner with GPV team and other quality units to support maintenance and compliance of PSMF on an ongoing basis
- Collect and monitor compliance metrics globally and evaluate possible trends
- Contribute quarterly metrics for quality management review
- Provide consultation to for possible quality issues, lead quality investigations and support completion of root cause analysis
- Provide input to corporate audit planning
- Establish partnership with corporate and affiliate quality units, with attention to harmonization of affiliate quality activities
- Minimum of 10 years of experience in GCP/GPV or GCP/GVP quality assurance
- Quality, processes, and compliance oriented
- Knowledge of GVP, government regulations and guidelines (EMA, FDA, PMDA) pertaining to pharmacovigilance
- Solid knowledge of IT structure and Information Database Systems (such as Oracle Argus, Trackwise)
- Ability to write standard operating procedures
- Ability to manage multiple projects and priorities
- Bachelor’s degree in life science required (PhD or PharmD preferred)
- Excellent communication and negotiation, customer service oriented, and interpersonal skills
- Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment
- Results oriented, accountability, and delivery
- Strong interpersonal skills while building/keeping/monitoring quality and compliance
- Multitasks and ability to manage multiple global processes
- Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders.
- Our company developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.
- As the global leader in complement inhibition, our company is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.
- In addition, company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.