Assoc Director, GRACS External Operations / Local Supplier Management Job - India
- This position will be responsible and accountable for the local management and oversight of the Global Regulatory Affairs and Clinical Safety (GRACS) external partners (vendors).
- This individual will manage the vendor relationship of one or more strategic suppliers with the responsibility to facilitate, implement, and sustain the consistent application of a robust supplier management program.
- This will include review of aggregate supplier performance data to spot trends or issues, ensure issue escalation processes are followed, and provide recommendations to management for efficient and effective issue resolution.
- This India-based role will work closely with vendors supporting company GRACS activities, India-based company personnel as well as company personnel at other locations globally to achieve operational excellence from our vendors while maintaining quality, driving continuous process improvement, and developing partner relationships.
- The scope of GRACS Functional Area interactions will include at a minimum CMC, Operations & Quality Management, Regulatory Affairs, Clinical Safety & Pharmacovigilance, and Labeling.
- This position will be responsible for managing local implementation of the multi-year sourcing strategy to expand GRACS outsourcing capacity and is expected to leverage best practices and drive innovation in the context of GRACS and vendor relationships.
- This role will work seamlessly with colleagues in the GRACS External Operations to ensure the global program for sourcing is executed effectively.
- Responsibilities will include project management and oversight of partnership deliverables and timelines at the site level as well as management of supplier performance, issues, risks and opportunities. This role will engage and collaborate closely with company and external partner stakeholders to manage the supplier relationship and ensure effective partnership and continued growth. This will include management and continuous improvement of processes and enhancement of connections between the external partner and the various GRACS Functional Area groups to ensure that all global regulatory and safety submissions are efficiently and effectively delivered on time and of high quality.
- As additional sourcing activities are identified, this role will work to ensure the integration of new work with existing work at outsourced partners.
- The incumbent will require prior project management experience as well as a working knowledge of Regulatory Affairs, outsourcing, and supplier management with a strong track record of demonstrated leadership and capability to foster collaborative relationships.
Primary responsibilities include but are not limited to:
- Manage the relationship between company and the external partner(s) to effectively deliver on objectives.
- Provide project management and oversight for cross-functional deliverables and timelines at the site level; collaborate with cross-functional stakeholders and facilitate local discussions.
- Manage, track and escalate issues actively and appropriately
- Communicate and articulate vendor performance issues and due diligence outcomes to appropriate parties both internally and externally.
- Ensure Quality and Compliance by collaborating with Compliance colleagues, participating in audit activities and conducting local oversight.
- Monitor and manage vendor performance by collaborating with internal teams and external parties to ensure delivery of sourced submission works through clearly defined objectives. Aggregate performance metrics and support root cause analysis. Provide regular feedback to External Ops management, internal teams and external partners.
- Support innovation and opportunity management and drive continuous improvements. Actively collaborate with and provide guidance to vendors to assure new capabilities and services are developed and existing capabilities and processes are assessed and improved (on an ongoing basis), and assuring consistent application of roles and processes across projects.
- Work closely with HQ GRACS External Operations head to implement multi-year sourcing strategy.
- Actively participate in and effectively prepare for Sourcing Governance committee interactions.
Required: Bachelor’s degree
Preferred: Advanced degree and/or MBA preferred
- Solid knowledge and experience in Supplier Management models
- Experience working in a drug development outsourced model (either on the supplier or client side), with an ability to translate learnings to a regulatory and clinical safety submissions outsourcing model.
- Minimum of 6 years project management or oversight experience
- Knowledge of drug development, specifically regulatory, CMC, and global safety processes for pharmaceutical products, vaccines and/or biologic products.
- Minimum of 8 years experience within the healthcare/consumer care industry, regulatory affairs or pharmacovigilance function that includes working with external partners.
- Strong interpersonal, communication and leadership skills.
- Ability to lead by influence and work effectively in matrix organizational structures.
- Experience managing vendor relationships and/or resolution of issues in a cross- functional environment.
- Strong negotiation skills.
- Demonstrated ability to build and maintain relationships with individuals across multiple locations.
Direct experience supporting regulatory or CMC filings across a variety of submission types.
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