Supplier Compliance Manager - Devens, MA
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Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Position Summary : This position is responsible for providing investigation technical support, supplier process improvement, and scientific expertise and compliance knowledge to fulfill BMS requirements to implement supplier changes.
Duties / Responsibilities :
- 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 findings 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 place for each change control, monitor and ensure actions are implemented and closed on time and status updated 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.
- Reporting Relationship : Daily contacts with SQE Team, Global Supplier Management Team, MS&T Scientists, Site Supply Chain Buyers, and Site Quality Management. Frequent contact with Site General Manager, Site Quality Head, Site Leadership Teams, Site / HQ Finance, Global Category Leaders, and Suppliers.
Minimum Education Required : Bachelors
Job Category : Management
Additional Qualifications / Responsibilities :
Qualifications required : Bachelor's degree in Business, Science, or EngineeringSix (6) years of experience in Quality, Purchasing, or Manufacturing Technology (Technical Services) within the pharmaceutical, biologics, cell therapy, or medical device industryMS / MBA / CPIM / ASQ / Lean Manufacturing / Procurement experience is a plusAt least 3 years handling investigations processAt least 3 years handling change control processMust have proven track record of successfully managing projects, and responsible for developing & implementing quality processes in a pharmaceutical environmentStrong customer service orientation with excellent analytic, interpersonal communication, and negotiating skillsProactive, creative and analytic approachStrong understanding of supplier development & supplier quality experience is a mustShort-term execution and long-term strategic thinking capabilities, ability to multitask with a sense of urgencyAbility to interface with external resources and internal resources at all levelsDemonstrated hands on supplier management implementation in regulatory agencies like : FDA, ANVISA, COFEPRIS, EMEA, BfArM, JP, MHRA among othersAbility to communicate effectively within a matrix organizationEffective at selling ideas, services, and solutions to others at different organizational levels and functionsDemonstrates leadership, interpersonal, communication, and motivation skillsExcellent writing and oral communication skills are requiredWorking Conditions : No exposure to hazards or disagreeable conditions. Travel required (describe nature and frequency) : 10% of the time
The starting compensation for this job is a range from US-MA- $105,330-$127,600 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.