harbaheadercoverblack.png

Supplier Quality Assurance Manager

Fishers $100,000 - $125,000 Permanent

Job Responsibilities

  • Lead & Develop the Team: Guide a group of supplier quality specialists by setting expectations, coaching regularly, and encouraging a culture focused on improvement and compliance.

  • Supplier Oversight: Create and manage processes for bringing new suppliers on board, evaluating risks, performing audits, and tracking ongoing performance for materials, components, and outsourced services.

  • Quality System Management: Oversee the systems that support supplier quality, including vendor approval workflows, inspection requirements for incoming goods, and performance scorecards aligned with regulated-industry standards.

  • Regulatory Alignment: Make sure all supplier-related quality activities meet global health authority expectations and are carried out in accordance with applicable guidelines.

  • Audit Execution: Coordinate and perform supplier audits—from initial qualification to routine reviews and investigations—while ensuring findings are well documented and followed by effective corrective actions.

  • Process Optimization: Spot opportunities to streamline processes, reduce delays, and support operational growth while strengthening compliance.

  • Cross-Functional Support: Work closely with procurement, manufacturing, labs, and regulatory teams to embed supplier quality needs into overall business processes.

  • Risk & Supply Continuity: Assess supplier risks, create mitigation plans, and respond to supply-chain issues to minimize disruption to production activities.

  • Reporting & Documentation: Keep thorough records, track supplier performance, prepare summaries for leadership, and support documentation needs during regulatory reviews.

  • Change Review: Assess and approve proposed changes from suppliers, ensuring risks are evaluated and testing or regulatory notifications happen when required.

  • Training & Expertise: Build and deliver training related to supplier quality expectations and maintain up-to-date knowledge of evolving regulations.

Requirements

  • Bachelor’s degree in a scientific, engineering, or related field.

  • At least seven years of experience in pharmaceutical quality roles, including three years specifically in supplier quality oversight.

  • Strong understanding of regulations and guidelines relevant to quality systems and pharmaceutical manufacturing.

  • Experience evaluating, qualifying, and routinely monitoring suppliers.

  • Proven ability to enhance quality processes and lead improvement initiatives.

  • Strong communication skills and the ability to work effectively with both suppliers and internal teams.

Share this job:

Apply now

Similar Jobs

Operations Engineer

Noblesville $90,000 - $100,000 Permanent

Job Responsibilities Track, manage, and close out operational and engineering reliability projects and improvement initiatives....

Senior Process Engineer

Indianapolis 100K - 130K Permanent

Responsibilities Monitor and analyze manufacturing data to support process optimization and investigations. Participate in process FMEAs to ev...

Quality Systems and Compliance Manager

Indianapolis $120,000 - $140,000 Permanent

Job Responsibilities Build, maintain, and oversee a quality system that aligns with industry expectations for regulated manufacturing and...

Senior Quality Control Technician

Noblesville $24 - $28/HR Contract

Job Responsibilities Run a range of routine and advanced analytical tests using chromatography, spectroscopy, titration, and similar scien...

Quality Control Technician

Noblesville $20 - $23/HR Contract

Job Responsibilities Carry out a variety of analytical tests using instruments such as chromatography systems, spectroscopy tools, titrati...