Supply Chain Compliance Specialist
- Employer
- Bristol Myers Squibb Company
- Location
- Devens, MA, United States
- Start date
- Jun 8, 2019
View more
- Discipline
- Clinical, Clinical Medicine, Regulatory, Legal/Compliance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown, Best Places to Work
Job Details
- Lead investigation teams for Supply Chain department including management of resulting CAPAs & SOP revisions
- Supply Chain Dept Change Control gatekeeper: Facilitate Supply Chain Leadership Team (LT) review to assess change control impact & change actions. Create pre/post action items in Trackwise following LT review
- Manage the periodic review program for the Supply Chain Dept; work with functional areas to complete assessments. Revise SOPs with focused revision scope
- Provide support during regulatory agency and internal inspections. Coordinate responses to regulatory, internal and external compliance requirements with Supply Chain supervisors and managers
- Partner with Supply Chain leadership and relevant departments to manage the Supply Chain training curricula (Dept Training program owner). Deliver training resulting from CAPAs, procedure revisions,& other requirements
Manage Supply Chain Quality Systems Portfolio
- Represent the Supply Chain department at cross-functional huddles (i.e. investigation, change control & CAPA). Effectively & efficiently source information on item status from the Supply Chain team & hold team members accountable. Facilitate resolution of items at risk of on-time completion; escalate unresolved risks for on-time completion
- Manage the Supply Chain Dept portfolio of work for on-time completion of investigations, CAPA/tasks, change control actions & periodic reviews (metrics)
Operational Excellence & Project Leadership
- Lead (cross-functionally) or represent Supply Chain on Priority 2 (site level cross functional) and/or Priority 3 (Dept level) projects. May represent the Devens site Supply Chain on Priority 1 (network level) projects.
- Support & participate in the site Operational Excellence program. Drive opportunities & projects for continuous improvement
- Participate in site safety initiatives to improve safety culture
Influence & Mentor
- Communicate with cross-functional leaders to inside and outside of Supply Chain to drive successful outcomes for the site and functional business unit
- Act as a mentor to group members for quality and compliance tasks. Ensure compliance across all areas of Supply Chain including verification of followed procedures through routine compliance checks and documentation review
Knowledge &Skill
- Knowledge generally gained by course of study for a Bachelors degree or its equivalent
- A minimum of 2-4 years of (combined) experience in a regulated manufacturing environment (Warehouse, Quality, etc)function with experience in supply chain processes, investigation management, process mapping and regulatory knowledge
- Project work is required with the ability to collaborate cross-functionally with other groups and levels
- Critical skills include a high degree of initiative, strong problem solving skills & attention to detail
- Excellent communications and computer skills with a demonstrated proficiency with MS Access, Word, Excel, PowerPoint & Project
- Ability to work independently and participate in project teams. Able to communicate will all levels of Management, develop successful working relationships, and possess an ability to influence site team members.
- Able to communicate effectively and develop successful working relationships
- Experience with SAP and TrackWise desirable
Company
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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