Job Title: Senior Raw Materials Quality ConsultantJob Description
The Senior Raw Materials Quality Consultant leads a strategic initiative to enhance and optimize the global Raw Materials Program for commercial manufacturing operations. This role evaluates and improves raw material qualification processes, strengthens quality systems and documentation, and ensures alignment with GMP and regulatory requirements across the full product lifecycle. The consultant provides deep subject matter expertise in raw materials and consumables, driving risk-based, compliant, and efficient practices that support high-quality, safe products.
Responsibilities
- Lead and support the completion of a strategic initiative focused on improving and enhancing the global Raw Materials Program for commercial manufacturing.
- Evaluate existing raw material qualification processes and identify opportunities for procedural and operational improvements.
- Ensure raw material quality systems align with commercial manufacturing and applicable regulatory requirements throughout the product lifecycle.
- Revise and improve existing Raw Materials Standard Operating Procedures (SOPs) to strengthen compliance, clarity, and usability.
- Author and implement new SOPs that support raw material lifecycle management and qualification activities.
- Develop associated SOP Forms (SOPFORMs) and supporting documentation to ensure consistent execution of raw material processes.
- Author, revise, and review specifications, procedural documents, quality records, and other controlled documentation related to raw materials.
- Ensure all documentation adheres to GMP, quality system standards, and data integrity requirements.
- Serve as the subject matter expert for raw material and consumable qualification activities across the product lifecycle.
- Support the development and refinement of qualification strategies for raw materials used in commercial manufacturing operations.
- Assess existing qualification programs and provide recommendations to improve efficiency, compliance, and risk mitigation.
- Establish and refine appropriate controls for material qualification, lifecycle management, and ongoing monitoring.
- Provide expertise in material release and disposition processes that support commercial manufacturing.
- Support investigations, assessments, and quality decisions associated with raw materials and consumables, including root cause analysis and corrective actions.
- Collaborate with Quality Control, Manufacturing, and Supply Chain teams to ensure compliant and effective material management practices.
- Provide technical guidance on sampling programs for both solid and liquid raw materials.
- Review and improve raw material testing strategies and programs to ensure robust control while optimizing resource use.
- Identify opportunities to reduce testing requirements while maintaining compliance, product quality, and patient safety.
- Support risk-based approaches to raw material testing and qualification, including risk assessment and mitigation strategies.
- Partner closely with Quality Control, Quality Assurance, Manufacturing, Supply Chain, Regulatory, and Technical Operations teams on raw material quality initiatives.
- Provide technical leadership and recommendations on raw material quality-related projects and continuous improvement efforts.
- Support project timelines and drive deliverables to completion with minimal oversight, ensuring milestones are met and outcomes are documented.
Essential Skills
- Bachelor"s degree in Chemistry, Biology, Pharmaceutical Sciences, Biochemistry, Microbiology, Chemical Engineering, or a related scientific discipline.
- Minimum of 10 years of Quality Control Raw Materials experience within the pharmaceutical, biotechnology, biologics, or broader life sciences industry.
- Extensive experience supporting commercial GMP manufacturing operations.
- Demonstrated expertise in raw material and consumables qualification programs across the product lifecycle.
- Strong understanding of commercialization and product lifecycle management as it relates to raw material controls and qualification.
- Significant experience with material release and disposition processes in a GMP environment.
- Proven experience authoring, editing, and reviewing GMP quality documents, including specifications and procedural records.
- Strong knowledge of raw material specifications, SOPs, SOP Forms, protocols, reports, and quality system documentation.
- Experience supporting both solid and liquid raw material sampling and testing programs.
- Deep familiarity with GMP, quality systems, and data integrity principles as applied to raw materials.
Additional Skills & Qualifications
- Experience working in pharmaceutical, biotechnology, biologics, or life sciences organizations undergoing commercialization.
- Ability to lead cross-functional initiatives and influence stakeholders in Quality Control, Quality Assurance, Manufacturing, Supply Chain, Regulatory, and Technical Operations.
- Strong analytical and problem-solving skills with a focus on risk-based decision-making for raw material testing and qualification.
- Ability to identify and implement process improvements that enhance efficiency, compliance, and risk mitigation in raw material programs.
- Comfort operating with minimal oversight while managing timelines, deliverables, and stakeholder expectations.
- Interest in contributing to the growth of an emerging biopharmaceutical organization and potentially transitioning to a full-time role based on performance.
Work Environment
This role operates within a small, growth-focused pharmaceutical environment in the Research Triangle Park (RTP) area. The company focuses on developing and commercializing innovative dermatology therapies, including FDA-approved treatments, and is actively expanding its product portfolio. You will work closely with cross-functional teams such as Quality Control, Quality Assurance, Manufacturing, Supply Chain, Regulatory, and Technical Operations in a collaborative, fast-paced setting. The environment emphasizes GMP-compliant operations, robust quality systems, and data integrity, offering the opportunity to shape a global raw materials program while contributing to therapies that address unmet patient needs.
Job Type & Location
This is a Contract position based out of Durham, NC.
Pay and Benefits
The pay range for this position is $60.00 - $90.00/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)
Workplace Type
This is a fully onsite position in Durham,NC.
Application Deadline
This position is anticipated to close on Aug 21, 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 actalentaccommodation@actalentservices.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.