Genentech Vendor Strategy Lead in South San Francisco, California,
Vendor Strategy Lead
South San Francisco, California
Job ID: 202105-111506 (http://jobs.gene.com/202105-111506)
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Summary of Position:
Based on identified risks and process gaps, the GVP Vendor Strategy Lead is responsible for developing and executing the strategic Service Provider Oversight Plan (SPOP) for ensuring GVP Vendor compliance per health authority and global Roche requirements. The GVP Vendor Strategy Lead makes all decisions around the day-to-day operations of the Service Provider Oversight Plan (SPOP), and continuously monitors feedback to inform quality improvements and updates. The GVP Vendor Strategy Lead executes the SPOP within the framework set by the GVP Vendor Strategy Manager and Head of PV Operations.
Liaise with business/functional units to influence the design of GVP Vendor processes ensuring adequate collection and processing of safety data and their timely reporting to the safety unit as per scope.
Perform risk assessments to ensure GVP Vendors have Quality Management Systems (QMS) in place.
Identifies risks and gaps within the vendor process. Develops strategic oversight plans for ensuring PV compliance for GVP vendors, including risk mitigation strategies.
Accountable for execution of SP Oversight Plan (SPOP).
Acts as a single point of contact for all vendor communications.
Makes all decisions around the day-to-day operations of the oversight plan.
Continuously monitors feedback to inform quality improvements and updates.
Act as Pharmacovigilance subject matter expert for GVP vendor processes in the event of audits or regulatory inspections.
Represents US affiliate on global workstreams or committees as required.
Use appropriate metrics and quality checks to gain sufficient oversight of the GVP vendor processes and its effectiveness, aiming to achieve a desired state of compliance.
Oversee and support implementation of vendor CAPAs, as appropriate.
Perform at least annual site visits to GVP vendors.
Communicates with vendors regularly as part of the communication plan to drive a desired state of collaboration.
Escalates issues and risks as appropriate to GVP Vendor Strategy Manager and/or PV Operations Head as appropriate.
Accountable for PV compliance for GVP vendors.
Competencies Identified for Success:
Ability to adapt in a regularly changing environment
Experienced with engaging key stakeholders
Strong organizational and project management skills
Strong influencing skills and collaborative approach with peers and senior leaders
Excellent communication skills, both written and oral
Works effectively as a team member and promotes collaboration
Appreciation for the importance of Pharmacovigilance compliance in pharma industry
Understanding of GVP and GCP regulations
Education, Experience, and Other Requirements:
Life sciences degree BSc minimum (or >10 years’ experience in a similar role)
3+ years in pharmacovigilance or compliance-related role
8-11 years pharma experience / 6-9 years pharma experience with Masters or RN / 3-6 years with PhD/PharmD
Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.
Who We Are
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
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