Kelly Services is actively recruiting for a Supplier Quality Manager for a Direct Hire opportunity in Greater Chicago area, IL.
The Supplier Quality Manager is responsible for maintaining and leading the Supplier Qualification activities and managing the supplier management program for the Clients Schaumburg site. This manager must effectively work with quality, regulatory, operations, laboratories, purchasing, engineering, finance, suppliers and CMO’s to ensure that suppliers are appropriately evaluated, monitored, qualified/disqualified and documentation is maintained. The Supplier Quality Manager ensures effective resolution of supplier issues, failures, changes, transfers/transitions as well as ensures Clients implements appropriate internal controls, monitoring, metrics, risk-mitigations, quality agreements, specifications and purchasing controls which render compliant components, materials, products and services by third parties.
Key Job Responsibilities:
- Managing and maintaining the Clients Supplier Quality Program and assuring compliance with all applicable global regulatory requirements and standards for vendors, suppliers, service providers, CMOs, OEMs and third parties.
- Provide strategic and risk-based leadership in the execution of Supplier Quality activities ensuring compliance to procedures, specifications and Quality Agreements as well as Purchasing, Distribution, Licensing agreements and contracts in place for Clients products, processes, roles and responsibilities.
- Creating and approving supplier evaluations, supporting documentation, quality agreements, assessment against regulatory requirements/standards, risk assessments and ratings for supplier activities/capabilities, review/approval of Supplier proposals including approval/rejection/restrictions, notice of changes, performance scorecards and Management Review metrics.
- Create and maintain the supplier audit program including performance scorecards, trending, metrics, audit planning, reports, responses and schedules.
- Monitoring and coordinating resolution of failures/actions/changes required for issues and notice of changes from Purchasing, Suppliers/Vendors, Service Providers, Contract Manufacturing Organizations (CMO), and Original Equipment Manufacturers (OEM).
- Applying risk-based strategic planning for Clients related actions, internal mitigations and containment activities, testing and inspection for supplier issues and evaluations, gap assessment results as well as ensuring failures/changes in supplier issues are evaluated, documented and approved in a compliant manner.
- Lead supplier continuous improvement plans and activities based on leading, lagging or failing indicators of performance.
- Initiate, review, approve, lead and manage timely handling of supplier exceptions, deviations, CAPAs, effectiveness verification and changes (new or revised) to minimize impact to production, supply chain, transition, tech transfer or any improvement initiative as well as ensure appropriate handling of any failures/changes with potential impact on product quality, safety, efficacy and impact to the regulatory filing, supplier status, purchase orders or quality agreement.
- Establish and maintain successful cross-functional relations with Design & Development, Engineering, Manufacturing, Operations, Quality Control, Quality Assurance, and Purchasing departments.
- Evaluate, monitor, define effective process monitoring which ensures that the commitments of the Quality Agreements and contracts are being fulfilled and help facilitate resolution in cases when they are not.
- Maintain governing procedures, forms, Approved Supplier List(s) and supplier files.
- Serve as a Subject Matter Expert during Internal and External inspections, audits, assessments, and remediation activities.
- Manage Supplier Quality budget and quality staff.
Experience / Background / Skillset:
- Bachelor's Degree required, preferably in a Science or Engineering discipline.
- 10 years experience in the pharma or medical device regulated industry in Quality Assurance, Compliance and Supplier quality related functions.
- 5 years experience in management of direct resources or cross functional teams in a Quality System, compliance and Supplier management role.
- Experienced in FDA requirements, regulatory expectations and standards related to Supplier Quality as well as compliance remediation, project management, risk management and gap assessments.
- Strong leadership skills to motivate and enable cross-functional personnel in meeting objectives, risk-based decision making, timeliness, personal accountability, product/process compliance and safety oriented.
- Strong written and verbal communication skills with effective documentation management skills and ability to communicate at all levels of the organization to drive changes, resolve issues, understand risks to compliance and the business.
- Experience in departmental budgeting and supervision/training/managing staff.
- Strong ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve results.
- Multi-tasks effectively, prioritizes and meets deadlines in timely manner.
- Strong organizational, planning, and follow-up skills and ability to hold others accountable by setting a strong leadership and compliance-minded example.
- Experienced, practical knowledge and application of the regulations and standards, (e.g. QSR, ISO13485, Quality System Requirements, CFR 211, 820, Part 11, ICH guidelines, Health Canada and Latin America regulations, FDA guidance documents), affecting Medical Device and Pharma manufacturing sites and supply chain as well as Quality System life cycle management.
- Demonstrated experience with development, implementation and management of quality system procedures and best practices.
- Proven ability to work successfully cross-functionally and collaboratively to problem solve, initiate and manage projects/changes, influence internal and external groups and provide leadership from a quality and compliance perspective.
- Proficient use of various software applications such as MS Teams, Word, Excel, Access, PowerPoint, Outlook.
If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.
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