Job Description

Job Title: Vendor Quality Manager

Job Location: San Francisco, CA, USA

Job Location Type: Remote

Job Contract Type: Contract

Job Seniority Level: Mid-Senior level

Job Duties/Responsibilities:

• Understands the vendor management framework set by the Head of MAP & Safety Partnering and translates the requirements into reporting deliverables (e.g., QA/QC metrics, action items, etc.). Works with the Vendor Lead on the oversight of GVP/MAP SPs.
• Supports the Vendor Lead on all operations performed, including the implementation of policies/procedures that ensure efficient and compliant operations.
• Ensures quality and PV requirements are met in accordance with contractual obligations. Facilitates and participates in SP oversight activities such as SP meetings.
• Develops agenda and facilitates meetings with SP.
• Tracks statuses for critical milestones and metrics.
• Creates action items and follow-ups on action items.
• Appropriately escalates to MAP Management Team and Vendor Lead as required.
• Communicates closely with local cross-functional teams within US PS to ensure the appropriate level of support is achieved to ensure oversight.
• Determines priorities and resource load balancing to manage backlogs, action items, and business as usual.
• Leads, coordinates, and collates QC error rates, QC metrics, trends, and gaps for the MAP Management and Vendor Lead.
• Leads or assists in the tracking and investigation of case processing-related metrics (e.g., late case investigation) including compliance-related issues set by the vendor management strategy.
• Understands the PV environment and works with Vendor Lead and Head of MAP and Safety Partnering to identify SP compliance risks.
• Monitoring Performance.
• Monitors SP compliance to applicable SOPs and Key Performance Indicators as detailed in the Service Agreement and global/local requirements.
• Oversees Corrective and Preventative Actions by the SP, as required.
• Supports MAP management and Vendor Lead during audits and inspections.
• Issue / Risk Management.
• Acts as a day-to-day point of contact with US PS SPs and ensures strong relationships and communication are built between the Company and the SP.
• Acts as a point of inquiry for any questions/concerns raised by the SP with appropriate resolution or escalation by the Company.
• Provides regular feedback on performance and quality checks to the SP working together with MAP Management and Vendor lead.
• Working together with the MAP Management and Vendor Lead communicates any processes or procedural changes.
• Escalates any critical decisions or discussions to the Vendor Lead and Head of MAP & Safety Partnering.
• Provides support to MAP Management and Vendor Lead by answering questions on Vendor Management reports and deliverables.
• Escalates SP risks to the Vendor Lead and MAP Management as required.
• Actively identifies process improvement opportunities, gaps, and risks and communicates to MAP Management and Vendor Lead to support continuous quality improvement.

Skills:

• Exemplifies strong, dynamic leadership and demonstrates decisiveness and appropriate decision-making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, prioritization of tasks in a timely manner within the scope of responsibility, and escalates identified issues to management in a timely fashion.
• Works effectively, independently, and collaboratively as a team member with global stakeholders and external business partners.
• Strong organizational skills, detail-oriented, and adapts to a fast-paced, changing environment.
• Demonstrates ownership, initiative, accountability, strong organizational skills, and is solution-oriented.
• Excellent communication skills, both written and verbal.
• Ability to actively exchange knowledge and ideas.
• Able to identify potential business gaps and leads in the development and implementation of process solutions.
• Able to handle the pressure associated with and adapts to a fast-paced, changing environment.
• Inspires others to do their best work by offering encouragement and support.
• Maintains personal and corporate integrity.

Education:

• Life sciences degree BSc minimum (or 10 years’ experience in a similar role).
• 5+ years in pharmacovigilance or compliance-related role required.
• Advanced analytic and computer skills (e.g., Microsoft Excel, other data visualization tools) preferred.
• Medical terminology experience preferred.
• Writing experience; science/medical writing highly desirable.
• Able to travel as per business needs required.
• Able to be agile and adapt to shifting priorities and needs.
• Able to be flexible to accommodate differences in vendor time zones.

The hiring range for this position is $35 to $41 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on the candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.

Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

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