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Project Manager QA

Spectraforce Technologies
United States, Texas, Waco
8301 Mars Drive (Show on map)
Aug 13, 2025

Position Title: Project Manager QA

Work Location: North Chicago, IL or Waco, TX

Assignment Duration: 12-month project

Position Summary: Responsible for quality of assigned products to ensure on-time delivery while assuring compliance with policies and global regulations.

Background & Context:



  • We are seeking an experienced Quality Assurance III professional to join a leading global eye care company, focusing on quality risk management within the manufacturing and oversight of small molecules, biologics, and related products.
  • The role will be centered on improving and maintaining quality systems, conducting risk management activities, and supporting smaller technical projects.

    Key Responsibilities:
  • Maintains the primary quality lead with management oversight for project activities and the team members (within and outside of our organization) to achieve on-time quality deliverables, high customer value, and profitable results.
  • Primary driver for the quality and compliance aspects of product transfers and organization optimization.
  • Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at our organization plants as well as third party manufacturing (TPM) facilities.
  • Implements agreed strategy.
  • Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers.
  • Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to our organization management.
  • Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled.
  • Helps facilitate resolution in cases where they are not.
  • Establishes and maintains relationships and open communication with Third Party Manufacturers, our organization plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.
  • Communicates and negotiates with external companies' quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide our organization with the agreed service.
  • Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.
  • Interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable.
  • Provides support for quality audits, initial site approvals and due diligence activities.
  • Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
  • Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer's that provide products directly to distribution centers, or to our organization domestic and International plants for further packaging and/or testing.
  • Coordinates activities to support follow-up on compliant trend investigations for non-medical and medical (adverse events).
  • Supports the management of exception documents and Corrective and Preventive Actions.
  • Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues.
  • Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner.
  • Lead quality risk management activities with a focus on aseptic manufacturing and associated processes.
  • Oversee assessments, identify gaps, and implement improvements to the quality system.
  • Apply and integrate risk management tools (e.g., FMEA, SRA, Truckwise, Linkus) into day-to-day operations.
  • Manage and execute multiple smaller technical quality projects (~10% of workload).
  • Conduct quality oversight for either API or finished drug product manufacturing (experience in one is sufficient).
  • Collaborate with global teams in Europe and California, no interaction with Asia.
  • Maintain internal quality management (QM) focus (95% of role; TPM involvement not required).
  • Ensure compliance with internal policies, regulatory requirements, and industry standards.
  • Track actions, maintain project documentation, and provide updates to stakeholders.
  • Utilize project management skills to drive initiatives to completion.

    Qualification & Experience:
  • Bachelor's Degree in relevant Life Science or other technical discipline or equivalent job experience required.
  • 7+ years of total combined experience.
  • At least 5 years in Quality Assurance Operations Management; 3 years in Operations, Research and Development or Consulting.
  • Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).
  • Proven experience in pharmaceutical quality systems and risk management; small molecule experience is critical.
  • Familiarity with aseptic processes and sterile manufacturing practices.
  • Proficiency with risk management methodologies (e.g., FMEA, SRA) and digital tools (Truckwise, Linkus).
  • Strong project management skills with the ability to manage timelines, deliverables, and priorities.
  • Excellent communication skills; able to work independently and in cross-functional teams.
  • Comfortable collaborating across global locations with flexible hours when required.


Notes:



  • We are seeking an experienced Quality Assurance III professional to join a leading global eye care company, focusing on quality risk management within the manufacturing and oversight of small molecules, biologics, and related products.
  • The role will be centered on improving and maintaining quality systems, conducting risk management activities, and supporting smaller technical projects.
  • The ideal candidate will have a strong background in small molecule product quality oversight, with expertise in risk assessment tools such as FMEA and SRA.
  • While pharmaceutical industry experience is strongly preferred, candidates from closely related regulated industries will be considered.

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