Piper Life Sciences is currently looking for a Quality Services Supervisor in West Chester, PA to support a cutting-edge Bio-Pharmaceutical and Medical Device Organization.
Responsibilities for the Quality Services Supervisor Include:
- Primary responsibilities include ensuring the teams managing several Supplier Quality projects adhere to procedural and project driven schedules, meet project team milestones; assist with remediating issues presented by team members and support the organization with maintaining focus on each program
- Supervise the team managing the Supplier Quality Agreement program.
- Ensure all Supplier Quality Agreements are reviewed and approved within the 3-year cycle.
- Assist with resolving Quality Agreement issues presented by the team
- Monitor and report out schedule performance on a monthly basis
- Assist with Supplier Quality Agreement negotiations as needed.
- Ensure all supplier assessments are executed by defined project timelines
- Monitor tasks associated with supplier readiness are conducted at each milestone
- Report out project status to the core team
- Collaborate with team members to complete milestones on or before defined timelines
- Collaborate with team members to develop procedures for project implementation.
- Develop communication strategy for project deployment
- Support quality initiatives such as executing CAPAs; issuing non-conformances; and inspection/audit support
- Support update of applicable Supplier Quality Procedures and Work Instructions
Qualifications for the Quality Services Supervisor I Include:
- Minimum of 3 years’ experience in a supervisory capacity
- Minimum of 3+ years of experience in a medical device and/or pharmaceutical industry
- Strong familiarity with ISO-13485 and FDA QSR
- Must be able to work independently, effective with a matrixed organization and prioritize with limited supervision. Strong written and oral communication and interpersonal (listening) skills.
- Proficient in Microsoft Office, EtQ, knowledge of SAP
- Three years of experience as Project Engineer, Quality Engineer, Project Manager or equivalent role within regulated industry
- Background in Supplier Management and Process Validation / Verification
- Understanding supplier validation procedures and execution
- Strong Project Management skills, must understand the critical path, identify program resources, setup project plan and track execution, establish project structure and governance around critical projects.
- Experience with Medical Device Regulatory Compliance/Regulatory Affairs.
- Experience with Quality Agreements and negotiating with suppliers across multiple sites and business centers
- Process Excellence Black Belt or Green Belt
- Ability to coach and guide core team on project expectations and track progress across multiple-sites and projects
- Ability to act as an SME in critical compliance and business processes
- Ability to provide regular updates to Quality leadership at various forums
- B.S. or B.A. degree or equivalent related experience
Compensation for the Quality Services Supervisor Includes:
- Full Benefits Including: Health, Vision, Dental, 401k plan