Manager of Regulatory Affairs and Quality Control, Solid Dose Dietary Supplement Manufacturing

Manager of Regulatory Affairs and Quality Control
Solid Dose Dietary Supplement Manufacturing

Company Profile
Since 1948, Marlyn Nutraceuticals has built a distinguished reputation as a leading developer and manufacturer of science-based natural supplement solutions. Our success is anchored in three fundamental pillars: adherence to cGMP-compliant natural formulations, a comprehensive understanding of services throughout the entire lifecycle of oral solid dosage forms, and a commitment to value-driven cGMP process development. From initial formulation and production to final packaging in a continuous manufacturing format, we enhance both efficiency and product quality, ensuring that our clients receive superior, reliable products that meet their needs.

Marlyn's Core Competencies

• Specialized Development and Manufacturing: We excel in the creation and production of nature-based solid dose supplements designed to support consumer health. Our expertise lies in deeply understanding our customers' needs, which drives our innovation and allows us to stay ahead of market trends. By leveraging cutting-edge research and development, we ensure that our products not only meet but exceed consumer expectations, delivering effective solutions that promote wellness and vitality.
• Comprehensive Oral Solid Dosage Handling: Proficient in the entire production process of oral solid dosage forms, including tablets, two-piece capsules, and drink powders, overseeing everything from manufacturing to inspection and packaging.
• Advanced Solid Dose Expertise: In-depth knowledge of effervescent and hygroscopic solid dose processing, allowing us to develop innovative and effective supplement formulations.
• State-of-the-Art cGMP Manufacturing Facility: Our modern facility is equipped with cutting-edge technology, ensuring high-quality production standards and regulatory compliance.
• Science-Driven Product Development: Commitment to cost-effective strategies for solid dose product development, leveraging scientific research and innovation to deliver competitive solutions in the market.

Market Position
We proudly serve leading clients in:

• Mass market retail
• National chain drug stores
• Pharmaceutical companies
• Global consumer goods brands

Technical Excellence
Our facility combines cutting-edge manufacturing technology with stringent quality controls to deliver:

• Consistent product performance
• Innovative and effective delivery systems
• Cost-effective production solutions
• Commitment to environmental sustainability and corporate responsibility

Position Overview
We are seeking an experienced and proactive Solid Dose Regulatory Affairs and Quality Control Manager to lead our small QC compliance and quality department with a hands-on approach. This pivotal role is crucial in ensuring adherence to FDA regulations and GMP standards within dietary supplement manufacturing. The ideal candidate will possess extensive operational knowledge of dietary Supplement 21 CFR Part 111 requirements , and regulations, empowering them to make informed decisions that enhance efficiency, troubleshoot challenges, and identify areas for continuous improvement.

In this position, the manager will be responsible for executing and performing assignments personally, demonstrating a commitment to quality and compliance in every task. The role requires strong multitasking abilities, effective prioritization, and strategic delegation to ensure that projects stay on track. Establishing efficient workflows and actively planning and prioritizing daily tasks will be essential to align the department’s operations with long-term strategic objectives. This hands-on leadership approach will drive the success of our quality and compliance initiatives while fostering a culture of excellence within the team.

Regulatory Compliance

• Oversee compliance with the Dietary Supplement Health and Education Act (DSHEA) and FDA regulations, particularly 21 CFR Part 111
• Manage supplement labeling compliance as per 21 CFR Part 101.36
• Direct FDA inspection readiness and timely responses
• Oversee regulatory submissions, product registrations, and compliance with 21 CFR 

 
Key Responsibilities
Regulatory Compliance:

• Ensure comprehensive compliance with DSHEA, FDA, FTC, and state regulations for dietary supplements manufacturing and marketing
• Oversee product labeling to accurately reflect ingredients, dosage, and health claims in adherence with FDA and FTC regulations
• Substantiate health claims made about Marlyn's supplements based on "competent and reliable scientific evidence" per FTC requirements
• QC and QA Regulatory Review: Approve and monitor testing protocols of ingredients and finished products to verify purity and potency, preventing adulteration and contamination
• Ensure Marlyn's manufacturing facility and processes adhere to all applicable requirements, including quality control measures
• Approve and monitor stability study protocols to confirm product shelf life and integrity
• Evaluate and engage third-party testing and certification programs (e.g., NSF International, USP) to provide additional quality validation

PD Regulatory Review:

• Verify ingredient selections are compliant with all applicable regulations, customer requirements and that calculated correction factors align to required label claims labeled claims
• Approve formulas and master batch records to assure compliance with all applicable regulations

QC Department Oversight:

• Approve workload plans and staffing proposed by the QC Manager
• Provide support to the QC Manager regarding issues or challenges with test methods, protocols, deviations, OOSs or other related quality or staff concerns
• Drive continuous improvement of in-house testing and certifications
• Facilitate QC’s collaboration with Marlyn’s technical and business groups

Communication:

• Effectively communicate information about potential regulatory changes and any compliance issues to relevant stakeholders
• Provide regulatory guidance and input during new product development to ensure feasibility of meeting regulatory and customer standards
• Lead Marlyn’s technical and quality discussions with our contract customers

Required Qualifications
- Bachelor’s degree in a relevant scientific field
- 8+ years of experience in the dietary supplement industry with a focus on regulatory affairs
- 5+ years of quality management experience
- Comprehensive knowledge of dietary supplement GMPs and regulatory frameworks
- Proven track record of successful FDA compliance and inspections
- Strong analytical laboratory background with experience in quality systems implementation

Benefits
- Competitive salary with performance-based incentives
- Comprehensive health benefits package
- 401(k) plan with company match to support your financial future
- Paid time off to promote work-life balance
- Professional development and training opportunities to foster career growth

Location: Phoenix, Arizona
Schedule: Full-time, Monday-Friday

Marlyn Nutraceuticals is an equal opportunity employer committed to workplace diversity. We are dedicated to creating an inclusive environment where all employees feel valued and respected.We believe in equality for everyone, regardless of age, sex, sexual orientation, race, color, creed, religion, ethnicity, national origin, disability, military or veteran status, or any other legally recognized protected basis under federal, state or local laws, regulations or ordinances.

Regulatory Affairs, Solid Dose Manufacturing, Quality Control, Dietary Supplements, GMP Compliance, FDA Regulations, cGMP Manufacturing, Solid Dose Formulations, Nutraceuticals, Validation Programs, Analytical Testing, Stability Testing, Risk Assessment, Product Development, Supplement Labeling Compliance, Continuous Manufacturing, Internal Audits, Supplier Qualification