Supplier Quality Assurance Manager Job at Harba Solutions Inc., Fishers, IN

U1BDTmZXaEJXQjlidUdycE5jcTI3bWo5dkE9PQ==
  • Harba Solutions Inc.
  • Fishers, IN

Job Description

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 auditsfrom initial qualification to routine reviews and investigationswhile 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
  • Bachelors 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.



#J-18808-Ljbffr

Job Tags

Similar Jobs

Express Employment

Tax Specialist Job at Express Employment

 ...preparation firm or financial services environment Familiarity with bookkeeping or payroll (optional) Benefits ~ Medical ~ Dental ~ Vision ~401K ~ Employee Assistance #CHAMILOS Express Office: Champaign 1001 North Mattis Avenue Champaign, IL 61821

PetSitter.com

Pet Sitter Wanted - Loving Dog Walker Wanted For Vacations And Occasionally Drop Ins Job at PetSitter.com

Job Posting:I hope you are having a good day. I am booking a petsitter working in Fredericksburg, Virginia. I plan to chat with a hard Working candidate who has drop in availability.Service Requirements:Our family requires help with pet sitting, and if available some...

RES Consultant Group

Remote Tax Accountant - CPA Firm - Hybrid Job at RES Consultant Group

 ...Nationally ranked CPA firm is hiring HYBRID tax professionals who have experience working in one or all of the following client industries; Construction, Real Estate, Pro Athletes, Manufacturing or Distribution. This a great opportunity to advance your tax career in this... 

The Global Talent Co.

Customer Service Representative (French Speaking) Job at The Global Talent Co.

 ...Customer Service Representative (French Speaking) Full-time (40-hours per week), Remote At The Global Talent Co., we provide opportunities to work with leading innovative technology companies worldwide, offering stable employment, competitive compensation, career... 

Endless Energy

BDR & Appointment Setter In-Person (Marlborough) Job at Endless Energy

 ...A premier home services company in Marlborough, MA is looking for a full-time Appointment Setter/Business Development Representative. You will be responsible for booking appointments, managing customer databases, and ensuring exceptional service delivery. The ideal candidate...