Hybrid Quality Lead (Pharmacovigilance Auditor) bei Roche
Roche · South San Francisco, Vereinigte Staaten Von Amerika · Hybrid
- Optionales Büro in South San Francisco
Are you a Pharmacovigilance auditor with an interest in performing risk assessments and developing quality strategies for assigned areas? Or are you a Pharmacovigilance expert who wants to gain auditing experience? If so, then this is the role for you!
The Opportunity
In Pharma Development Quality (PDQ) we strive for confidence in the integrity of our data and our processes, agility, and unrivaled transparency with health authorities, patients and society. Our work provides leadership, know-how and partnering on quality across Molecules, Products (Drug and/or Medical Devices), Pharma affiliates and global regulated processes.
We are looking for a Quality Lead (Pharmacovigilance Auditor) who brings a diversity of thinking and technical experience in pharmacovigilance / drug safety. The Quality Lead (Pharmacovigilance Auditor) will support the Roche/Genentech Organization through the design and delivery of pharmacovigilance related quality strategies. Quality strategies will have defined quality measures (critical to quality [CtQ] factors) and objectives based on business surveillance and the use of data analytics. The Quality Lead(Pharmacovigilance Auditor) will generate evidence and actionable data through the conduct of audits to assess the quality status and to be able to demonstrate effective implementation of quality assurance to stakeholders and Health Authorities.
Key Responsibilities
Define process/affiliate level approach with appropriate measures (CtQ factors) to enable oversight and management of quality
Design and implement quality strategies for the assigned PV related area (affiliates/PV process)
Assess specific pharmacovigilance related risk areas on an ongoing basis, communicate to PDQ senior leadership and propose modifications to the quality strategy where necessary
Actively lead or contribute in activities to assess quality status, including preparation, conduct, presentation and timely reporting of outcomes of audits, ensuring appropriate action plans are developed
Establish strong partnerships/relationships with business stakeholders
Prepare and present contextualized quality evidence, including conclusions, observations and associated compliance risks to business stakeholders and Pharma representatives
Lead or support inspection preparation activities and management of Health Authority inspections
Who you are
Your Profile
You are a highly motivated and committed professional with strong experience and technical knowledge in pharmacovigilance.
You have proven critical thinking and problem solving skills (curiosity, creativity and adaptability), with solid relationship management and influence. You ask the challenging questions and are comfortable in difficult conversations.
You have an in-depth understanding of the drug development process.
Required
Masters, Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience
Minimum 5 years in the pharmaceutical industry and/or pharmacovigilance experience
Demonstrated applied knowledge of pharmacovigilance / drug safety and regulatory requirements
Demonstrated excellent analytical, strategic thinking, and problem-solving skills with a proven ability to understand business impact
Excellent verbal and written communication and stakeholder management skills
Project management experience with proven leadership, mentoring and coaching
Desired
Proficiency in the conduct of GxP audits
Experience supporting Health Authority inspections
Proficiency in utilizing data and visualisation tools to generate insights
Your Application:
Please kindly provide a cover letter alongside your CV.
The interview process will consist of a screening video interview, followed by a case study presentation as part of the interview process.
Relocation benefits are not available for this job posting.
The expected salary range for this position based on the primary location of South San Francisco, CA is $111,000 to $206,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.