Bonafide Health · 7 hours ago
Quality Systems Manager
United States
Full-time
Remote
Senior Level
$100K/yr - $184K/yr
5+ years expBonafide Health is part of Pharmavite's Women's Health portfolio, dedicated to championing women's health and joy at every age. The Quality Systems Manager will implement and sustain the Quality Management System, focusing on quality requirements across suppliers, products, and internal teams.
BiotechnologyE-CommerceHealth Care
No H1B
Responsibilities
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
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
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
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
Qualification
Required
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
Preferred
Quality-related certifications preferred but not required
Benefits
Annual performance bonus
Medical, dental and vision benefits
401K match
Other wellness benefits
Company
Bonafide Health
Bonafide Health is a women’s health company that develops and manufactures nutraceutical and health products for menopause issues.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$25M2023-11-30Acquired
2021-01-01Debt Financing· $25M
Leadership Team
A
Alyssa Dweck
Chief Medical Officer
Recent News
2025-10-17
Bonafide® Health, LLC
2025-09-12
2025-09-09
Company data provided by crunchbase