Quality Assurance Manager (Consultant)

ZipRecruiter; Irvine (CA); Remote; USD 80,000 - 100,000; Full time

Job summary

An innovative company in the healthcare sector seeks a Quality Assurance Consultant to oversee quality standards for a groundbreaking OTC product launch. This role involves ensuring compliance with regulatory requirements, managing documentation, and collaborating with cross-functional teams to mitigate risks. The ideal candidate will have extensive experience in biopharmaceutical quality assurance and strong project management skills. This is a unique opportunity to contribute to the launch of a transformative health solution while working in a flexible remote environment.

Qualifications

• 5+ years of experience in quality assurance within biopharmaceuticals.
• Experience with OTC biopharma and consumer system quality standards.

Responsibilities

• Lead preparation and review of quality assurance documentation.
• Manage internal quality audits and regulatory inspections.

Skills

Quality Assurance

Regulatory Compliance

Risk Management

Project Management

Biopharmaceutical Manufacturing

Education

Bachelor's or Master's degree in Life Sciences

Advanced degree or certifications (e.g., ASQ, Six Sigma)

Tools

Quality Management Software

Document Control Systems

MS Office Suite

Job description

Job DescriptionJob Description

About the Company: Propedix is a biopharma and consumer health company dedicated to advancing innovative treatments in healthcare. Our flagship product, featuring our breakthrough anti-fungal and drying agent technology, launches in Q2 2025, with a pipeline of advanced OTC and Rx treatments in dermatology and health. Driven by strong research and development, we’re delivering the next generation of health solutions.

Position: Consultant Quality Assurance Consultant (acting Manager/Assoc Dir)

Position Overview:The Quality Assurance Consultant (acting Manager/Assoc Dir) will be responsible for ensuring the highest standards of quality throughout the product development lifecycle. This role is pivotal in preparing for the commercial launch in 2025 of an Over-The-Counter (OTC) athlete’s foot treatment by working closely with our Contract Manufacturing Organization (CMO) to develop and finalize critical quality documentation. The ideal candidate will have a solid background in biopharmaceuticals, experience with regulatory compliance, and the ability to manage complex QA activities that support the manufacturing and launch of new products.

Key QA Manager Responsibilities

Quality Documentation Preparation & Review: Lead the preparation, review, and finalization of essential quality assurance documentation to meet the regulatory requirements for commercial launch. This includes Vendor Qualification and Audits, Standard Operating Procedures (SOPs), and release protocols.

CMO Management and Oversight: Serve as the primary point of contact between internal teams and CMOs for all quality-related matters. Coordinate with external partners to ensure that manufacturing processes align with the company’s quality standards and regulatory requirements, including cGMP (current Good Manufacturing Practices).

Regulatory Compliance: Ensure that the company’s products and processes are compliant with global regulatory standards, including FDA and other relevant health authorities. Support the preparation and submission of quality-related documents for any OTC level regulatory filings.

Risk Management: Identify potential quality risks early in the development process, especially related to manufacturing and supply chain, and collaborate with relevant teams to mitigate these risks before the commercial launch.

Product Release & Commercial Launch: Oversee the release of products for clinical trials and the commercial market, ensuring that all batch release documentation and certifications are accurate and complete for the timely launch of the product in April 2025.

Internal Quality Audits & Inspections: Manage internal OTC standard quality audits and regulatory inspections, ensuring compliance with all internal and external quality requirements. Support preparation for inspections by regulatory authorities and third-party audits.

Cross-Functional Collaboration: Collaborate closely with Product Development, Regulatory Affairs, Manufacturing, and Supply Chain teams to ensure quality requirements are met at each stage of the product lifecycle, from development through to commercial launch.

Location:Virtual strong preference for candidates who reside in Southern California. Work can be performed remotely with attendance required for live meetings once a month. Travel out of region (in U.S.) expected 3 to 4 times a year.

Experience/ Necessary Skills

Education: Bachelor’s or Master’s degree in Life Sciences, Chemistry, Engineering, or a related field. Advanced degree or certifications (e.g., ASQ, Six Sigma) is a plus.

Experience:

• Experience with OTC biopharma and consumer system and quality standards required.
• 5+ years of experience in quality assurance within the biopharmaceutical or biotechnology industry, with a focus on cGMP-compliant manufacturing.
• Proven experience working with CMOs in preparing for commercial product launches, including development of quality-related documentation (BPRs, SOPs, Master Batch Records, etc.).
• Strong understanding of regulatory guidelines (FDA, OTC) and quality systems.
• Hands-on experience with risk management, CAPA (Corrective and Preventive Actions), and change control processes.

Skills & Competencies:

• In-depth knowledge of biopharmaceutical manufacturing processes and quality systems.
• Strong project management skills and the ability to prioritize and manage multiple tasks in a fast-paced environment.
• Knowledge and experience with OTC quality standards.
• Proficiency in quality management software, document control systems, and MS Office Suite.

Hours: Approx 10 to 15 hours a week until our first product launch (Q2 of 2025), then 6 hours a week thereafter. Candidates must be available for live meetings and email correspondence on average 1 hours a day during normal business hours. Attendance at a once-a-week management meeting (usually scheduled for Tuesday) a requirement.

Compensation. $5,000 to 7,000 per month when completing 10 - 15 hours per week, then $3,500/mo thereafter (approx 6 hours per week). This is an independent contractor 1099 position.

Support and Supervisor: Position will report to the CEO who will be their administrative supervisor. This position is expected to work closely on a daily basis with the CTO/VP of Product Development, Sr. Director of Manufacturing, Chair of Scientific Advisory Board, CCO, and all 3rd party production and component vendors.

Application: Interested parties should send their resume and a brief cover note to [e-mail].

Job Type: Contract

Work Location: Remote, with occasional travel for quarterly company meetings

ProPedix is an equal opportunity employer. We are committed to creating an inclusive environment for all employees. Our employment decisions are based on individual qualifications, job requirements and business needs without regard to , , marital status, sex, , and/or expression, , , , citizenship status, , , veteran status and or any other legally protected characteristics. We are committed to providing reasonable accommodation, if you need an accommodation to complete the application process, please email [e-mail]

ProPedix does not accept profiles or resumes from recruiting firms without a binding written agreement. Any unsolicited submission of services and/or resumes in no way creates an obligation by ProPedix, implied or otherwise.