Senior Manager Source Compliance

Job Summary

This position will provide Worldwide Source Compliance leadership in the development, implementation and continuous improvement of Source Compliance programs associated with Suppliers (External Manufacturers, Direct & Indirect Suppliers) associated with the business. They will be responsible for ensuring the post audit activities are executed per established procedures, such as Supplier Audit Response support & alignment, supplier action plan follow-up & closure, EM follow-ups, metric reporting, and support as needed for the maintenance and continually improvement of the Source Compliance process. They will engage with business partners, such as Supplier Quality & supplier relations and Suppliers. In addition, they will support external audits/inspections at business sites and suppliers as required.

Duties & Responsibilities

• Working with suppliers to ensure a robust Supplier Audit Response (SAR) & aligning on all second pass SARs.
• Tracking to completion all supplier audit observations.
• Execution of Follow-ups for External Manufactures (EMs).
• Data analysis & Metric reporting.
• Working with suppliers and internal observation owners to achieve Green supplier audit Metrics.
• Preparation of Source Compliance slides.
• Partnering with internal partners such as ERC auditors & SPOCs, Quality & Supplier relations to establish and maintain robust supplier relationships and supplies.
• Will establish and execute the Compliance strategies for the management of Suppliers.
• Recruit, develop and manage direct reports and contractors.
• Support external audits/inspections at sites and suppliers as required.
• Lead Source Compliance input to Executive Management review for the assigned business.
• Support the development and review of external Health Authority and notified body responses related to supplier/purchasing control observations to ensure robust investigations, corrective actions, and timing.
• Provide periodic data and analytics to business partners, including compliance data & current global health authority trends that enable the organization can deliver on quality and compliance commitments.
• Develop proactive approaches to address regulatory trends.
• Provide oversight and compliance review of Suppliers remediation programs.
• Lead and/or contribute to strategic Source Regulatory Compliance initiatives and projects.
• Provides visibility to the business on new supplier related Health Authority regulations or changing expectations and results of Health Authority inspections.
• Establish and manage the assigned Source Compliance budget.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Experience and Education

• A Bachelor’s degree in Business, the sciences or Engineering is required. A Master’s Degree or other Advanced Degree is preferred.
• A minimum of 8 years of combined experience in Regulatory Compliance and/or Quality in Medical Devices or pharmaceutical products is required. Medical Device experience is preferred.
• Strong knowledge of FDA & Global Medical device regulations & Medical device standards such as ISO 13485 is required.
• Knowledge and experience in executing investigations and developing Corrective actions is required.
• Experience in managing professional associates is required.
• Experience working with suppliers is required.
• Ability to engage senior management in identifying critical needs and to ensure effective deployment across the sector is required.
• Demonstrated ability to work remotely and partner globally is required.
• Ability to foster an effective multi-functional, cross region, cross company team environment is required.
• Experience in actively participating in external inspections is preferred.
• Auditing experience, especially supplier auditing is preferred.

Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations

• Strong communication (written and verbal) skills are required.
• Strong leadership, partnering, influence, negotiation and change management skills are required.
• People leadership, Project management, problem solving, investigation and presentation skills are required.
• Auditor certification is preferred.