Supplier Quality Engineer (Pharmaceuticals)

Job Description

Job Description

Job Title: Supplier Quality Engineer
Job Description

The Supplier Quality Engineer (Engineer, Supplier Quality III) ensures quality excellence and regulatory compliance across manufacturing operations in a highly regulated environment. This role supports inspection readiness, material movements, client audits, and supplier quality and material compliance activities, ensuring products consistently meet stringent standards while contributing to a mission of making the world healthier, cleaner, and safer. As part of the Supplier Quality Group, you will help maintain compliance with FDA, EMA, and other cGMP regulations, as well as specific client requirements, while fostering a culture of continuous improvement and operational excellence.

Responsibilities

• Support site inspection readiness activities to ensure the facility and quality systems remain compliant with FDA, EMA, and other cGMP regulatory requirements, as well as client expectations.
• Oversee and coordinate material movements to ensure that incoming materials and components meet defined quality and regulatory standards.
• Participate in and support client audits and regulatory inspections, including preparation, facilitation, and follow-up on audit findings and commitments.
• Work closely with suppliers to resolve supplier quality issues, including investigating nonconformances and implementing effective corrective and preventive actions.
• Manage supplier-initiated change controls by assessing impact, coordinating internal reviews, and ensuring appropriate approvals and documentation.
• Lead or support risk assessments related to supplier materials, processes, and changes, using formal risk management tools and methodologies.
• Administer and manage Supplier Corrective Action Requests (SCARs), ensuring timely investigation, root cause analysis, corrective action implementation, and effectiveness verification.
• Implement and maintain quality initiatives that enhance supplier performance, product quality, and regulatory compliance.
• Support and enhance quality systems, including CAPA, deviation management, change control, risk management, and document control.
• Conduct or support internal and external quality audits of suppliers and internal processes, documenting findings and driving closure of actions.
• Oversee or support validation and qualification activities related to supplier materials, processes, and equipment, ensuring adherence to protocols and regulatory expectations.
• Utilize electronic Quality and Training Management Systems to manage documentation, training, deviations, change controls, and related quality records.
• Apply advanced problem-solving and root cause analysis tools to address quality issues and drive continuous improvement.
• Collaborate with cross-functional teams, including manufacturing, engineering, procurement, regulatory, and quality control, to align on quality requirements and resolve issues.
• Prepare, review, and maintain quality documentation, including procedures, reports, and records, to support a robust quality management system.
• Use statistical analysis and quality tools to monitor supplier performance, analyze trends, and propose data-driven improvements.
• Manage multiple projects and priorities, ensuring timely completion of quality-related tasks and initiatives.
• Communicate effectively with internal stakeholders, suppliers, and external customers or regulators to convey quality expectations, findings, and resolutions.
• Travel up to approximately 25% of the time, as needed, to support supplier audits, assessments, and quality-related activities.

• 7–10 years of experience in Quality Assurance with a BS degree in a STEM field, or an advanced degree plus at least 3 years of experience, or a bachelor’s degree plus at least 5 years of experience in quality assurance within a regulated industry.
• Background in pharmaceutical or medical device industries, with a strong preference for pharmaceutical experience; experience in a GMP or regulated environment is required.
• Strong knowledge of cGMP and applicable regulatory requirements, including FDA, EMA, and other relevant guidelines.
• Hands-on experience with quality management systems, including change control, root cause analysis, deviation management, documentation management, and training systems.
• Experience using electronic Quality and Training Management Systems to manage quality records and training compliance.
• Demonstrated expertise in CAPA and deviation management, including investigation, corrective action planning, and effectiveness verification.
• Proficiency in change control processes, including impact assessment and implementation oversight.
• Experience in risk management and FMEA methodologies for evaluating and mitigating quality risks.
• Strong skills in document control, including authoring, reviewing, and maintaining controlled documents.
• Experience conducting or supporting internal and external audits, including supplier audits and regulatory or client inspections.
• Proven capability in supplier quality management, including working directly with suppliers to address quality issues and manage SCARs.
• Experience with validation and qualification protocols related to materials, processes, or equipment.
• Knowledge of statistical analysis and quality tools for monitoring performance and driving improvements.
• Advanced problem-solving and root cause analysis skills applied in a regulated quality environment.
• Strong project management abilities, with experience managing multiple quality initiatives and deadlines.
• Excellent verbal and written communication skills for interfacing with internal teams, suppliers, and external customers or regulators.
• Proficiency with quality management software and MS Office applications.
• Ability to work both independently and collaboratively within cross-functional teams.
• Strong attention to detail while maintaining a broad perspective on overall quality and regulatory compliance.
• Ability and willingness to travel up to approximately 25% of the time for supplier and quality-related activities.

• Bachelor’s degree or higher in Engineering, Life Sciences, Chemistry, or a related technical field.
• Advanced degree in a relevant technical discipline is beneficial.
• ASQ certifications such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) are desired.
• Experience in biotechnology in addition to pharmaceutical or medical device industries is advantageous.
• Demonstrated experience in regulatory compliance, including interpretation and application of FDA, EMA, and other global regulations.
• Exposure to process improvement initiatives and methodologies within a quality or manufacturing environment.
• Experience providing validation oversight for supplier-related processes and equipment.
• Familiarity with quality control principles, including testing, inspection, and release criteria for materials and products.
• Strong interpersonal skills for building effective relationships with suppliers and cross-functional partners.
• Additional language skills beyond English are beneficial for working with global suppliers and stakeholders.

This role is primarily office-based and desk-focused, operating in a professional setting that supports large-scale biological and chemistry pharmaceutical operations. The position follows a Monday–Friday schedule with normal daytime hours, offering flexibility as long as core hours are covered. You will work with electronic Quality and Training Management Systems, quality management software, and standard office tools such as MS Office, while collaborating closely with cross-functional teams in a fast-growing, global organization. The environment emphasizes impactful work, innovative thinking, and a strong culture of doing things the right way for the right reasons, with the customer at the center. The work directly supports the manufacture of biologics, such as large-scale protein production used in pharmaceuticals for conditions like autoimmune diseases. The organization invests heavily in research and development and provides resources and opportunities for colleagues to realize their full potential, contribute to meaningful scientific and quality outcomes, and build an exciting, long-term career.

Job Type & Location

This is a Contract to Hire position based out of Saint Louis, MO.

The pay range for this position is $38.00 - $48.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Saint Louis,MO.

This position is anticipated to close on Jun 26, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.