Supplier Quality Manager II
927 S Curry Pike Bloomington, IN 47402 Bloomington, IN 47402 US
Target Pay Rate: 135-155k **salary will be commensurate with experience
The Quality Manager, Supplier Quality, is a member of the Quality Assurance Leadership Team reporting directly to the Quality Manager, Compliance. They provide leadership and direction for and participates in supplier qualification activities.
What you'll do:
- Provides guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
- Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assists in setting performance objectives and development plans.
- Creates/Develops a strong team by setting clear direction and empowering members to obtain results that support strategic objectives.
- Develops and oversees the supplier qualification process and leads requirement completion initiatives, including supplier on-site audits (vendors of API, raw materials, components, and services which support pharmaceutical manufacturing).
- Responsible for ensuring Supplier Quality requirements are performed and processed in a timely manner (e.g., audits, supplier re-evaluations, quality agreement negotiation and implementation, risk assessment/mitigation, SCAR (supplier corrective action report), part/service approvals, supplier notices of change).
- Implements, evaluates and improves the effectiveness of purchasing controls and supplier quality processes and procedures.
- Serves as Supplier Quality subject matter expert during Client audits and Regulatory Inspections.
- Ensures that audit schedules are produced and communicated in a timely fashion.
- Plans and develops audit assessment strategies and logistics. Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies and recommends appropriate corrective actions.
- Evaluates corrective and preventive action responses to audit findings for adequacy, including root cause and timeliness.
- Collaborates with Purchasing and Incoming Quality Control teams as needed to ensure supplier requirements are met.
- Collects, trends and reports supplier quality metrics to ensure supplier monitoring requirements are met.
- Improve quality systems at selected suppliers to improve the overall compliance of the QMS.
What you'll bring:
- Bachelor's degree required; preference in a Life Science field.
- Minimum 8 years experience in Quality (Auditing or Supplier Quality functions).
- Minimum 5 years experience in a leadership role.
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise and eQMS software (examples include: TrackWise, JDE, etc.)
- Responsibilities require up to 50% travel, including internationally. Flexibility for remote work while not performing supplier audits.
- Travel requirements include routine on-site visits to Bloomington, IN and/or Halle, Germany to collaborate in person with team members.
- ASQ and/or RAB auditor accreditation is desired.
- Knowledge of pharmaceutical regulations, e.g., ISO 13485, ISO 9001, FDA cGMP, Eudralex, other global aseptic manufacturing regulations.
- Business Acumen; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her industry, business, and organization.
- Collaboration and Teamwork: Good communications, facilitation, coordination, and team skills.
- Project management skills managing multiple issues of moderate to high complexity relatively independently with minimal supervision/instructions.
- Responsible for managing department financial budget.
- Multi-tasking skills in a demanding fast paced environment.
- Superior written and oral communications skill sets.
Physical / Safety Requirements
- Duties require the ability don Grade C gowning in order to enter classified areas.
- Duties may require overtime work, including nights and weekends.
- Use of hands and fingers to manipulate office equipment is required.
- Position requires sitting for long hours, but may involve walking or standing for long periods of time.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.