Quality Manager

We are looking for a positive, driven, and detail-oriented Senior Quality Specialist to join our growing team on our mission of staying the #1 Probiotic Supplement Company in the US. This person will be responsible for verifying the Company’s quality program by using established quality policies to measure, monitor and ensure compliance with government regulations such as FDA. This individual will work closely with Physician’s Choice internal and external stakeholders (including but not limited to marketing, quality, 3rd Party Suppliers, raw material suppliers, regulatory agencies, trade associations, etc.) to support new product development, supply chain, and sales in commercializing new products that are safe, efficacious, high quality and compliant with all applicable regulations.

The ideal candidate has 7 years progressive Quality and Product Development experience in probiotics, nutritional supplement or other cGMP regulated industry. This is a full-time remote position reporting to the Chief Supply Chain Officer.

What You’ll Do:

Quality Management Systems

• Lead the development, implementation, and maintenance of the site’s Quality Management System (QMS) in compliance with regulatory requirements.
• Oversee the updating and maintenance of the site master file, facility registrations, training matrix, and compliance-specific job descriptions.
• Conduct and oversee periodic reviews of Quality Systems and present findings and recommendations to senior leadership.
• Lead internal audits for compliance with 21 CFR Part 111, ensuring regulatory adherence and continuous improvement.
• Provide coaching and guidance to department managers on non-conformances, documentation errors, and compliance gaps.
• Develop, implement, and oversee training programs on quality control procedures, ensuring staff competency and regulatory compliance.
• Drive continuous improvement by streamlining and simplifying existing quality system procedures.

Document Control & Recordkeeping

• Establish and maintain document control systems, ensuring accurate filing of SOPs, approved suppliers, approved products, and QA logs ( deviations, OOS, RCA/CAPAs, investigations, complaints, change control, testing).
• Supervise the drafting, review, and approval of critical quality and regulatory documents including COAs, COCs, formulas, specifications, SOPs, logs, and reports.
• Oversee the updating of all finished product specifications using formulas, labels, and test result COAs, ensuring alignment with regulatory standards.
• Manage the review and approval of FPS (Finished Product Specifications), ensuring compliance with quality and regulatory requirements, including testing methods, labeling, and packaging specifications.
• Implement and enforce guidelines for data collection, reporting procedures, and document retention policies to support regulatory audits and inspections.

Batch Release Management

• Ensure products are quarantined upon receipt, AQL inspected, retains kept, and samples sent to approved laboratories for testing.
• Oversee batch release activities, ensuring timely QA approval for market distribution.
• Review and approve manufacturing, packaging, and testing records to verify compliance with product release requirements.
• Lead the investigation and resolution of OOS (Out of Specification) and RCA/CAPA cases, coordinating MRB discussions and determining appropriate corrective actions.
• Approve master manufacturing records, planned deviations, change requests, and product releases, ensuring compliance with industry regulations and company standards.
• Manage and oversee manufacturer investigations for non-conforming products, ensuring root causes are identified and corrective/preventive actions are implemented.

Supplier Qualification & Compliance

• Develop and oversee the supplier qualification program, ensuring proper documentation and compliance with GMP (Good Manufacturing Practice), food safety, and regulatory requirements.
• Establish and maintain supplier compliance records, including SAQs, GFSI/GMP certifications, food defense programs, audit reports, test results, and other qualification documents.
• Lead periodic audits of Contract Manufacturers and Contract Laboratories to ensure compliance with cGMP standards.
• Act as the primary liaison with suppliers and external manufacturers to drive quality improvements and compliance.

Leadership & Strategic Initiatives

• Provide leadership and mentorship to the quality assurance team, fostering a culture of quality, accountability, and continuous improvement.
• Develop and execute quality strategies that align with company objectives, ensuring operational efficiency and regulatory compliance.
• Collaborate with cross-functional teams, including operations, R&D, regulatory, and supply chain, to maintain high-quality standards across all products and processes.
• Represent the company during regulatory inspections, audits, and customer quality assessments, ensuring successful outcomes.

Requirements

Education:

• Bachelor's degree (B. A.) from a four-year college or university preferred or an equivalent combination of four to six years related experience and/or training; or equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job.

Years of experience:

• Minimum 7 years of experience working within Quality in support of cGMP manufacturing or similarly regulated environment.

Type of Experience:

• Working within Quality in support of cGMP manufacturing or similarly regulated environments.
• Working knowledge of FDA regulations and guidelines, including 21 CFR part 101, 111, and 117.
• Understanding of Good Documentation Practices and Document/Records Controls

Certifications:

• PCQI
• HACCP
• Vendor Qualification
• Internal Auditing

Technical Skills:

• Ability to read, analyze, and interpret common scientific and technical documents.
• Ability to perform root cause analysis and implement appropriate CAPAs.
• Ability to understand and calculate basic formula inputs for comparison against label claims and technical documents.
• To perform this job successfully, an individual should have knowledge of Word Processing software; Spreadsheet software; Database software and Project Management system

Soft Skills:

• Strong communication skills, problem solving skills, attention to detail

ABOUT OUR COMPANY:

Our founder, Logan Chierotti, almost lost his hearing as a teenager. When modern medicine couldn't help, natural supplements restored his hearing. This life-changing moment inspired Logan to establish Physician's Choice in 2017. After 5 years of extraordinary sales growth, Physicians Choice is on pace to do over $150MM in sales and is the # 1 probiotic brand on Amazon, with Brick and Mortar distribution in Walmart, Target, CVS, SAMs Club and over 70,000 retail touch points.

Our mission is to empower everybody to make confident wellness choices, guided by physician expertise and validated by real results. We do this by collaborating with leading physicians to develop straightforward, accessible probiotic supplements that deliver on promises. Join our passionate team and be part of a company making a real difference in people's lives.

WHAT'S IN IT FOR YOU:

Our commitment to quality and transparency applies not only to our products but to our people. We are focused on creating a fun, exciting, collaborative space that’s centered around health and well-being. We continue to grow Physician's Choice with Team Players that support and live out our core values of Passion, Curiosity, Proactiveness, Resourcefulness, and Getting Sh@# Done. We empower everyone on our team to take control of their careers and balance their work and life in a modern, fast-paced environment.

We offer an exceptional compensation package which includes:

• Day one health benefits with multiple options to best fit your healthcare needs
• 401k match up to 4%
• Paid maternity and parental leave
• $150/quarter wellness benefit
• $75/month cell phone reimbursement
• $100/month in free company product
• Free lunch twice a week in our Wheat Ridge Office
• Free office snacks
• Paid Holidays
• Generous self-managed paid time off program
• Work-life balance and a fun environment
• Casual dress code
• Mentorship Program
• Professional growth and development within the organization
• Company Annual Bonus, 6-24% bonus targeted dependent on hitting annual goals
• Stock Appreciation Rights Bonus Program