Manager, PV Quality and Compliance, Contractor (Office OR Remote)
Description
We are searching for a creative, resourceful, integrative thinker for an important role that will be
responsible for PV quality and compliance activities with key support of PV audit and inspection activities.
The successful candidate will have a proactive and innovative approach and a flexible, hands-on nature that works with high sense of urgency. Primary responsibilities include but are not limited to participation of the PS&PV inspection and audit readiness program, project management, PV agreements, Safety compliance monitoring and training activities. The candidate will also assist with miscellaneous tasks within the PV Quality and Compliance function supporting the infrastructure, systems and processes.
This position requires a candidate with strong cross-functional skills and communication, a desire to help the team meet fast-paced growth and be self-motivated. Collaboration includes Quality, Clinical Operations, Regulatory Affairs and external Contract Research Organizations (CROs) and Safety vendor.
Responsibilities
Audit and Inspection Activities:
- Participate in the development of inspection readiness program for Patient Safety and PV involving health authorities, contract service provider, business partners with Safety Compliance lead and Arcus Quality organization.
- Participate and assist with audit and inspection backrooms activities, audit requests - pre- and ongoing throughout the audit.
- Support and coordinate with Subject Matter Experts (SMEs) for participation in audit and inspection readiness activities such as preparedness sessions, storyboards development and process knowledge presentations, preparation and review of Standard Operating Procedures (SOPs),
- Project manage, document and monitor tracking of action items to completion.
- Actively assist with audit and inspection responses.
Miscellaneous
- Support activities as needed under PV Agreements and Investigator Sponsored Trials (ISTs) contracts regarding oversight and tracking of deliverables, Compliance Monitoring of established Key Performance Indicators (KPIs) for CROs and Safety Vendor, PS&PV trainings.
- Participate in project management of daily email triaging, tracking, actioning follow-ups to tasks and maintaining deliverable trackers.
Experience
• Solid experience in audit and inspection readiness involving health authorities, PV contract service providers and PV business partners.
Strong safety quality systems, compliance monitoring, and the development and maintenance of standards and training programs.
• Strong knowledge and experience with available drug safety database systems, preferred Argus, document management systems, QC tools and Veeva Quality System.
• Expert knowledge of FDA, EMA, Asia-PAC, and ICH regulations and guidelines.
• Demonstrated problem-solving and critical thinking skills.
• Excellent interpersonal, communication, analytical, and organizational skills.
• Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment.
• Track record of strong personal performance combined with demonstrated ability to work collaboratively with high performing teams.
• Strong people and project management experience with attention to details.
Qualifications
• Minimum of Bachelor’s level degree in nursing, pharmacy, or other health care related field.
• Minimum 4 – 6 years in the pharmaceutical industry setting; minimum of 2 years’ experience working in Safety and Pharmacovigilance, specifically within PV Quality and Compliance with audit and inspection readiness experience.
• Oncology experience is preferred
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets