Compliance Manager

The compliance manager will provide investigation technical support, supplier process improvement, and scientific expertise and compliance knowledge to fulfill BMS requirements to implement supplier changes.

• Perform investigations, using eQMS (Infinity) system, for Supplier Complaints including but not limited to BMS and Supplier's processes.
• Create and execute Corrective Actions and Preventive Actions (CAPA).
• Prepare, submit and discuss finding of the investigation process with key stakeholders.
• Lead global investigations in collaboration with Global Quality Supplier Leads, BMS Site Supplier Quality, and SQE teams.
• Perform trending analysis of site events and complaints. Investigate and root-cause "no-fault found" investigations and implement internal process improvements to prevent reoccurrence.
• Generates, reviews and implements procedure and forms to assure compliance with current practices or GMP trends.
• Provides support to the supplier development team preparing quarterly data for Quality Council and governance meetings.
• Evaluates and improves supplier complaint investigation and material return process.
• Creates, evaluates, follows up and approves Change controls for the assigned site, including interaction with corporate support areas, other BMS sites and third parties.
• Ensures Change controls are created according to approved SOPs and corporate directives with all the appropriate requirements in placed for each change control, monitor and ensure actions are implemented and closed on time and status up-dated in related quality system. Escalate to supervisor and site procurement lead in case of issues.
• Create detailed plans of the activities using Project Management tools.
• Provides support, training and development to the suppliers and internally to avoid BMS and Suppliers issues recurrence.
• Implements processes and procedures to address supplier performance deficiencies.
• Ensure compliance with corporate and site procedures, cGMPs regulations and other industry guidelines.
• Apply Lean Six Sigma tools to reduce investigations establishing proper corrective, preventive and proactive actions.
• Manages and executes supplier program for the investigation and resolution of deviations, CAPA, and complaints.
• Provides oversight of suppliers performing investigations, change controls, protocols and reports in support of BMS products.
• Support additional projects, QMS initiatives, or standard work assignments as needed.

• Bachelor's degree in Business, Science or Engineering.
• Six (6) years of experience in Quality, Purchasing, or Manufacturing Technology (Technical Services) within the pharmaceutical, biologics, cell therapy, or medical device industry.
• MS/MBA/CPIM/ASQ/Lean Manufacturing/Procurement experience is a plus.
• At least 3 years handling investigations process.
• At least 3 years handling change control process.
• Must have proven track record of successfully managing projects, and responsible for developing & implementing quality processes in a pharmaceutical environment.
• Strong customer service orientation with excellent analytic, interpersonal communication and negotiating skills.
• Proactive, creative and analytic approach.
• Strong understanding of supplier development & supplier quality experience is a must.
• Short-term execution and long-term strategic thinking capabilities, ability to multitask with a sense of urgency.
• Ability to interface with external resources and internal resources at all levels.
• Demonstrated hands on supplier management implementation in regulatory agencies like: FDA, ANVISA, COFEPRIS, EMEA, BfArM, JP, MHRA among others.
• Ability to communicate effectively within a matrix organization.
• Effective at selling ideas, services and solutions to others at different organizational levels and functions.
• Demonstrates leadership, interpersonal, communication, and motivation skills
• Excellent writing and oral communication skills are required.