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Quality Director Supplements Jobs in Raleigh, NC

GT Independence

Registered Nurse

Raleigh, NC · On-site

Ensure all medications (prescription, OTC, alternative, supplements, etc.) are documented in the ... Compliance & Quality Assurance * Collaborate with the Director of Operations and GT Independence ...

GT Independence

Registered Nurse

Raleigh, NC

$70K - $80K/hr

Ensure all medications (prescription, OTC, alternative, supplements, etc.) are documented in the ... Compliance & Quality Assurance * Collaborate with the Director of Operations and GT Independence ...

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All JobsQuality Supplements JobsQuality Director Supplements JobsQuality Director Supplements Jobs in Raleigh, NC

Quality Director Supplements information

See Raleigh, NC salary details

$30.1K

$122.1K

$207.5K

How much do quality director supplements jobs pay per year?

As of Aug 26, 2026, the average yearly pay for quality director supplements in Raleigh, NC is $122,094.00, according to ZipRecruiter salary data. Most workers in this role earn between $88,500.00 and $146,800.00 per year, depending on experience, location, and employer.

What does a quality director in the supplements industry do?

A Quality Director in the supplements industry is responsible for overseeing the quality assurance and quality control processes throughout the production of dietary supplements. They ensure that all products comply with regulatory standards, such as FDA guidelines and Good Manufacturing Practices (GMP). Their role also involves developing and implementing quality management systems, managing audits, and leading teams to resolve quality issues. The Quality Director plays a crucial part in maintaining product safety, efficacy, and consistency to protect consumers and the brand’s reputation.

What are the key skills and qualifications needed to thrive as a quality director in the supplements industry?

A Quality Director in the supplements industry requires deep knowledge of quality assurance, regulatory compliance (such as FDA cGMPs), and a degree in life sciences or a related field. Familiarity with quality management systems (QMS), laboratory information management systems (LIMS), and certifications like Six Sigma or ASQ Certified Quality Auditor are typically expected. Outstanding leadership, problem-solving abilities, and communication skills help drive cross-functional teams and foster a culture of continuous improvement. These competencies are vital to ensure product safety, regulatory compliance, and the company's reputation in a highly regulated and competitive market.

What are some common challenges faced by a quality director in the supplements industry, and how can they be managed?

A Quality Director in the supplements industry frequently faces challenges such as keeping up with evolving regulatory requirements, ensuring supplier compliance, and managing product recalls or discrepancies. These challenges can be managed by building robust quality management systems, maintaining strong relationships with suppliers, and providing ongoing training for staff on Good Manufacturing Practices (GMP). Additionally, fostering a culture of continuous improvement and proactive risk assessment helps in addressing issues before they escalate, ensuring product safety and regulatory compliance.

What is the difference between Quality Director Supplements vs Quality Assurance Manager?

AspectQuality Director SupplementsQuality Assurance Manager
CredentialsTypically requires a Bachelor's or Master’s in Quality Management, Engineering, or related field; certifications like ASQ CQE or Six Sigma are commonUsually holds a Bachelor’s degree in Quality, Engineering, or related area; certifications like ASQ CQE or Six Sigma are often preferred
Work EnvironmentStrategic leadership in supplement manufacturing, overseeing quality policies and complianceOperational role focused on daily quality assurance activities and process improvements
Industry UsageCommonly used in supplement manufacturing companies to set quality standardsWidely used across supplement companies to manage quality assurance processes

While both roles require quality certifications and focus on product quality, the Quality Director Supplements has a strategic, leadership role overseeing overall quality policies, whereas the Quality Assurance Manager handles day-to-day quality operations and compliance.

What are popular job titles related to Quality Director Supplements jobs in Raleigh, NC?

For Quality Director Supplements jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Quality Director Supplements jobs in Raleigh, NC look for?

The top searched job categories for Quality Director Supplements jobs in Raleigh, NC are:

What cities near Raleigh, NC are hiring for Quality Director Supplements jobs?

Cities near Raleigh, NC with the most Quality Director Supplements job openings:

Quality Director Supplements jobs near you
Infographic showing various Quality Director Supplements job openings in Raleigh, NC as of August 2026, with employment types broken down into 1% As Needed, 76% Full Time, 18% Part Time, 4% Contract, and 1% Nights. Highlights an 88% Physical, 3% Hybrid, and 9% Remote job distribution, with an average salary of $122,094 per year, or $58.7 per hour.

Associate Director or Director, CMC Regulatory Affairs

Durham, NC • Remote

Atsena
See more jobs at Atsenaexternal

Full-time

Re-posted 11 days ago

Job description

Position Summary:

The Associate Director / Director, CMC Regulatory Affairs will lead global CMC regulatory strategy and execution for the company’s gene therapy programs from early research through clinical development and commercialization. This role is responsible for developing CMC regulatory strategies across product development stages, supporting regulatory submissions, and serving as the regulatory liaison to internal CMC teams and external contract manufacturing organizations.

The individual will work cross-functionally with process development, analytical development, manufacturing, quality, and program leadership to ensure that CMC development plans meet regulatory expectations for gene therapy products. The role will also support interactions with global regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency.


Key Responsibilities:

CMC Regulatory Strategy

  • Develop and implement global CMC regulatory strategies for gene therapy programs from early development through clinical stages and commercialization.
  • Provide regulatory guidance on viral vector manufacturing, process development, analytical characterization, and product comparability.
  • Assess regulatory risks related to manufacturing changes and propose mitigation strategies.

Regulatory Submissions

  • Lead preparation and review of CMC sections of global regulatory submissions, including: INDs and IND amendments, CTAs and IMPDs, BLA/MAA submissions and supplements, annual reports and regulatory updates
  • Ensure submissions meet regulatory expectations for gene therapy products.

Health Authority Interactions

  • Prepare CMC regulatory briefing documents and support agency meetings.
  • Serve as the subject matter expert for CMC topics during interactions with agencies including the FDA and EMA.
  • Coordinate and author responses to regulatory agency questions related to CMC.

Cross-Functional Collaboration

  • Partner closely with internal teams including: Process Development, Analytical Development, Manufacturing, Quality
  • Serve as the CMC regulatory representative on cross-functional program teams.
  • Provide regulatory guidance for manufacturing changes, comparability strategies, and lifecycle management.

Regulatory Intelligence & Compliance

  • Monitor evolving regulatory guidance related to gene therapy and advanced biologics.
  • Interpret regulatory requirements and communicate implications to internal teams.
  • Support development of internal regulatory policies and processes.


Qualifications:

Education

  • PhD or MS in biochemistry, molecular biology, chemical engineering, pharmaceutical sciences, or related field.

Preferred Qualifications

  • Direct experience with AAV, lentiviral, or other gene therapy platforms.
  • Experience supporting late-stage development or BLA/MAA submissions.
  • Familiarity with global regulatory frameworks for advanced therapy medicinal products (ATMPs).
  • Prior experience participating in regulatory meetings.

Associate Director Experience

  • 7–10 years of experience in regulatory affairs and CMC.
  • Experience contributing to CMC sections of IND/CTA submissions.

Director Experience

  • 10–15+ years of experience in regulatory affairs with leadership responsibility for CMC regulatory strategy.
  • Demonstrated experience leading CMC regulatory submissions and health authority interactions.

Knowledge & Skills

  • Strong knowledge of global CMC regulatory requirements for biologics and gene therapies.
  • Understanding of viral vector manufacturing processes.
  • Experience with analytical characterization, comparability, and manufacturing changes.
  • Excellent regulatory writing and communication skills.
  • Ability to work effectively in a fast-paced startup environment.

Key Competencies

  • Strategic thinking and problem solving
  • Strong scientific and regulatory expertise
  • Cross-functional leadership
  • Excellent communication and collaboration skills
  • Ability to manage multiple programs and timelines