Associate Director, Office Of Product Saftey Team Resource Operations
USA, Illinois, Lake County
Research & Development
This position reports into the Office of the Product Safety Team (PST) within the Pharmacovigilance and Patient Safety (PPS) organization's Global PV Strategy Management Office. The PPS organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand and communicate the safety profile of our drugs to protect patients worldwide.
The Office of the Product Safety Team (OOPST) plays a critical role in shaping and driving the strategic priorities of the PST through providing project management and operational leadership. The PST leads and owns safety decisions and strategy across the product lifecycle.
The OOPST Associate Director of Resource Operations develops, executes and oversees the external resourcing strategy (i.e. outsourcing strategy) for the Product Safety Teams. This role plays a critical role in partnering with PST stakeholders, and external partners (e.g. outsourcing vendors) to ensure that the PST's resourcing engagements are aligned to the PST priorities and overall business objectives, as well as deliver on resourcing goals (e.g. financial, deliverable quality, deliverable timeliness)
Develop, execute, and oversee resource strategies for the PST, specifically outsourcing. Engage key PST stakeholders to build an outsourcing roadmap that identifies prioritized short and long term outsourcing opportunities. Maintain roadmap and adapt to evolving business needs and emerging capabilities in the outsourcing industry
Proactively identify opportunities to leverage outsourcing to build flexible resource capacity in the PST model and/or build/strengthen business capabilities. Develop compelling business cases used to align key stakeholders on the proposed opportunities. Build alignment and gain endorsement. Prepare and deliver senior leadership updates on outsourcing engagements
Lead implementation of PST outsourcing engagements. Define KPIs for each PST outsourcing engagement. Provide execution leadership and own accountability in delivering expected results. Accountable for building and maintaining the financial model for outsourcing engagement
Partner with PPS Strategic Resourcing Operations to identify qualified outsourcing partners, develop outsourcing contracts, implement outsourcing extensions, support contract negotiations and resolve vendor issues. Actively promote sharing of best practices with other outsourcing managers across PPS
Oversee development and execution of onboarding, training and readiness of vendor teams. Accountable for all readiness activities related to Vendor Qualification Assessment, as well as any resulting CAPAs
Accountable for monitoring compliance and quality of all PST outsourcing activities. Proactively identify and address vendor performance issues. Remove internal barriers to success of vendors' work. Manage vendor relationships. Identify and drive initiatives to improve operational performance of outsourcing engagements
Partner with OOPST leadership and Business Process Office to ensure seamless alignment of processes for internal and outsourced work. Monitor, understand and address impact of regulations on outsourcing engagements. Proactively identify and address impact of PPS business decisions on outsourcing engagements
Continuously assess PST stakeholder satisfaction with outsourcing engagements and make agile modifications to increase satisfaction levels. Ensure successful partnership between the PSTs and the outsourcing vendors. Influence day-to-day activities that impact successful implementation of outsourcing engagement. Drive accountability and alignment of roles/responsibilities across the PSTs to enable success
Accountable for driving readiness activities (related to outsourcing engagement) for inspections and audits as well as leading responses to pre-audit requests. Act as SME, when required.
May be responsible for hiring, coaching, training, onboarding and managing performance of direct reports. Responsible for building and nurturing a culture of strong resource management excellence.
Minimum of 5 years' experience in pharmacovigilance, drug development or related pharmaceutical industry experience.
Proven experience with managing vendors and demonstrated ability to deliver on engagement metrics
Demonstrated people management experience.
Strong leadership presence. Ability to work directly with and influence senior management. Decisive yet collaborative leadership style.
Demonstrated ability to develop and deliver clear compelling business cases to senior leadership.
Established track record leading cross-functional projects within a global company.
Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/ guidelines
Proven ability to lead, manage, and motivate others in a complex, multi-functional matrix environment
AbbVie is an Equal Employment Opportunity employer: At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Travel: Yes, 10 % of the Time
Job Type: Experienced