Quality Assurance Consultant

Redeployment; California (MO); Remote; USD 80,000 - 100,000; Part time

Job summary

An innovative firm in the biopharma sector is seeking a Quality Assurance Consultant to lead the quality assurance department and build a robust Quality Management System. This part-time role offers flexibility while requiring expertise in OTC treatments and regulatory compliance. The successful candidate will engage with cross-functional teams to ensure high-quality documentation and compliance with internal standards. With a focus on launching a novel product, this is a unique opportunity to make a significant impact in healthcare. If you are passionate about quality assurance and thrive in a dynamic environment, this role is perfect for you.

Benefits

Flexible Work Hours

Remote Work

Travel Expenses Covered

Qualifications

• 5+ years of QA experience in biopharma/biotech with a focus on cGMP.
• Experience building a Quality Management System from scratch.

Responsibilities

• Lead preparation and review of quality documentation and vendor qualifications.
• Oversee CMO manufacturing processes ensuring compliance with FDA/OTC.

Skills

Quality Assurance

Regulatory Compliance

Risk Management

CAPA

Project Management

Education

Bachelor’s or Master’s in Life Sciences

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

Tools

Quality Management Software

Document Control Tools

MS Office

Job description

QUALITY ASSURANCE CONSULTANT

JOB TITLE: Manager/Associate Director; Quality Assurance Consultant

LOCATION: Remote, CA; expected roughly once per quarter at HQ (Irvine) and periodically at other manufacturing locations

Part Time; 8-15 hrs/week varying (described below)

Redeployment was created to match great people with great Life Science companies! We have been hired by a biopharma company that is advancing innovative treatments in healthcare with a site in Irvine and a satellite location in Boston. We are looking for an accomplished Quality Assurance Consultant (Manager/Associate Director) to lead the quality assurance department and build out the Quality Management System as our client company prepares to launch their flagship product into the market.

CANDIDATE MUST BE:

• ABLE TO CONSULT FOR 12+ MONTHS AT THE NUMBER OF HOURS DESCRIBED BELOW (part time)
• ABLE TO BEGIN WORK ON/BEFORE JUNE 1ST.
• EXPERIENCED IN OTC (OVER THE COUNTER) TREATMENTS AND DRUGS
• EXPERIENCED WITH BUILDING A QMS SYSTEM FROM SCRATCH

RESPONSIBILITIES:

• Lead preparation and review of quality documentation, including vendor qualifications, SOPs, and release protocols.
• Serve as the primary liaison for quality-related communications between internal teams and CMOs.
• Oversee CMO manufacturing processes to ensure compliance with internal standards and regulatory (FDA/OTC) requirements, including cGMP.
• Support regulatory filings by providing compliant, high-quality documentation for OTC submissions.
• Identify and manage quality risks, particularly in manufacturing and supply chain activities.
• Manage batch release documentation to support timely product release for clinical trials and commercial launch.
• Conduct internal audits and support regulatory inspections, ensuring compliance with internal/external standards.
• Collaborate cross-functionally with Regulatory, Product Development, Manufacturing, and Supply Chain teams.

QUALIFICATIONS:

Required:

• Bachelor’s or Master’s degree in Life Sciences, Chemistry, Engineering, or related field
• Experience with OTC biopharma and consumer quality systems.
• 5+ years of experience in biopharma/biotech QA, with cGMP manufacturing focus.
• Proven record of CMO engagement and preparation for product launches.
• Strong understanding of regulatory guidelines, quality documentation, and systems (specifically in the OTC markets)
• Hands-on experience with risk management, CAPA, and change control.

Preferred:

• Advanced certifications (e.g., ASQ, Six Sigma)
• In-depth knowledge of biopharma manufacturing processes.
• Strong project management skills in fast-paced environments.
• Proficiency with quality management software, document control tools, and MS Office.

LOCATION & WORK EXPECTATIONS:

• Remote position; strong preference for candidates in Southern California or the Bay Area.
• Must attend live monthly/quarterly meetings; occasional U.S. travel (3–4x/year). (covered by employer)
• Weekly time commitment:
• 10–15 hours/week until mid 2025 launch
• 6–8 hours/week post-launch
• Must be available for emails and virtual meetings during business hours (~1 hour/day).

COMPENSATION:

• $5,000–$7,000/month pre-launch (for 10–15 hours/week)
• $4,000/month post-launch (approx. 8 hours/week)
• 1099 independent contractor role

REPORTING & TEAM COLLABORATION: Reports to the CEO. Works closely with: – CTO / VP of Product Development – Sr. Director of Manufacturing – Chair of Scientific Advisory Board – CCO and all 3rd-party production vendors

Consultant will be expected to start immediately (before June 1st 2025). Interviews will be conducted as soon as 24 hours after application and will progress rapidly, with start/date, reference checks, background checks, etc all being done as quickly as possible – please have these ready.

CANDIDATES WITHOUT specific experience working with over the counter treatments/drugs in the past will not be considered. This person will be expected to operate independently as the subject matter expert, with minimal oversight by leadership.

About The Company

Our client is a biopharma and consumer health company preparing to launch a novel over-the-counter treatment utilizing proprietary anti-fungal and moisture-control technology in 2025. With a strong emphasis on research and development, the organization is building a pipeline of innovative dermatological and healthcare solutions across both OTC and prescription markets.

Redeployment is defined as “the process of moving people to a different place or using them in a more effective way.” We are a recruiting and executive search firm that uses our size and unique background to provide a personalized hiring experience to startups as they raise money, expand their business, and grow their team. With a focus in the biotech space, our expertise is getting to know and understand company culture, ensuring the RIGHT prospects are connected to the RIGHT companies. Reach out today!