Quality Systems Manager

About Women’s Health

Bonafide, Uqora and Equelle comprise Pharmavite's Women's Health portfolio. Collectively, these brands are driven by their promise to champion women's health and joy at every age.

Our People

Our Women’s Health team is composed of highly experienced professionals dedicated to making a meaningful impact. Bring your whole self to our Women’s Health brands — you’ll be welcomed by a team that shares your passion, purpose, and pride in our products while embracing your unique talents, creativity, and collaborative spirit.

This role is not available for sponsorship, including I-983 participation.

JOB SUMMARY                                                                        

The Quality Systems Manager plays a key role in implementing and sustaining Bonafide Health’s Quality Management System (QMS) in alignment with the company’s QMS roadmap. This role is focused on translating quality requirements into consistent, repeatable, and scalable execution across suppliers, products, and internal teams.

The Quality Systems Manager will own several core quality programs—including supplier quality management, document control, CAPAs and deviations, and customer complaints—and work cross-functionally to ensure quality processes are followed, documented, and continuously improved. As the QMS matures, this role will support future quality system implementations and integrations.

This is an execution-focused role well suited for someone who thrives in building structure, owning programs end-to-end, and collaborating closely with stakeholders in a fast-paced environment.

KEY RESPONSIBILITES

Critical contributions this role is counted on to deliver include:

Document & Change Control

• Lead and govern the document and change control processes, ensuring changes are appropriately assessed, approved, implemented, and verified for effectiveness.
• Establish and maintain documents and change control standards, ensuring documentation remains accurate, current, traceable, and inspection ready.

Supplier Quality

• Lead the supplier quality program, ensuring supplier qualification, re-qualification, and ongoing oversight are risk-based and current.
• Oversee supplier performance and drive corrective actions, including SCARs, escalation, and effectiveness verification for recurring or high-risk issues.

CAPAs, Deviations & Customer Complaints

• Lead the CAPA, deviation, complaint management and adverse events programs, ensuring investigations are timely, root causes are robust, and corrective actions are effective.
• Analyze trends across these programs to identify systemic issues and drive cross-functional continuous improvement.

Data, Reporting & Continuous Improvement

• Define and monitor quality KPIs to assess program effectiveness, identify risks, and support leadership decision-making.
• Provide regular quality performance updates to stakeholders and drive continuous improvement initiatives aligned with QMS maturity and business priorities.

WHAT SUCCESS LOOKS LIKE IN THE ROLE

• Execution-oriented: You enjoy owning programs and driving them to completion.
• Organized and detail-focused: You value documentation, traceability, and consistency.
• Process-minded: You understand how supplier quality, CAPAs, deviations, and complaints fit within a broader QMS.
• Collaborative: You work well with cross-functional partners and external stakeholders.
• Continuous improvement–driven: You look for ways to strengthen processes over time.

REQUIRED QUALIFICATIONS

In order to take on these challenges, you’ll need to have:

• Bachelor’s degree in a scientific discipline or equivalent hands-on experience.
• 5-8 years of experience in an FDA-regulated industry.
• Working knowledge of applicable cGMP regulations (e.g. 21 CFR 111, 117, 210/211, 820)
• Experience working with contract manufacturers, suppliers, and third-party laboratories.
• Quality-related certifications preferred but not required.

OUR OFFER

Here, career paths aren't predefined, and bureaucratic limitations don't exist -- you have the opportunity to grow, learn from industry pioneers, and develop the way you want to. Our Women's Health brands are investing more in the development of our team -- to help us deliver on our purpose and help you achieve your career aspirations. Our environment is geared to fuel curiosity, encourage experimentation, and generate learning