Senior Manager, Quality Systems

Supergoop!•New York, NY

7d•Onsite

About The Position

Supergoop! is seeking a strategic and hands-on Senior Manager, Quality Systems to build, implement, and lead a robust, scalable Quality Management System (QMS) across our product lifecycle. This role will oversee both Quality Assurance (QA) and Quality Control (QC) functions, ensuring our products consistently meet regulatory requirements, internal standards, and customer expectations. The ideal candidate brings deep experience in cosmetic, OTC, or personal care manufacturing and thrives in a fast-paced, high-growth environment. This role will partner cross-functionally with Innovation (Product Development and Packaging), Regulatory, Operations, Supply Chain, and external manufacturing partners to embed quality at every stage from formula development to finished goods release.

Requirements

Bachelor’s degree in Chemistry, Chemical Engineering, Biology, Pharmaceutical Sciences, or related field (Master’s preferred).
7+ years of quality experience in cosmetics, OTC, pharmaceutical, or personal care manufacturing.
Strong knowledge of FDA OTC regulations, cosmetic GMP (ISO 22716), and global regulatory frameworks.
Demonstrated experience building or significantly improving a Quality Management System.
Experience managing contract manufacturers and global suppliers.
Strong background in CAPA, root cause analysis, auditing, and risk assessment.
Experience preparing for and supporting regulatory inspections.
Excellent analytical, communication, and leadership skills.
Ability to thrive in a fast-paced, high-growth brand environment.
Strategic and systems thinker.
Detail oriented with strong documentation discipline.
Strong decision making and problem solving ability.
Collaborative cross functional leader.
Continuous improvement mindset.
High level of integrity and accountability.

Responsibilities

Design, implement, and continuously improve a comprehensive Quality Management System aligned with FDA OTC requirements, cosmetic GMPs (21 CFR Parts 210/211 where applicable), ISO 22716, and other relevant global standards.
Establish and maintain quality policies, procedures, SOPs, and work instructions across the organization.
Develop quality metrics and KPIs to monitor performance and drive continuous improvement.
Lead management review processes and quality reporting.
Champion a culture of quality and accountability across internal teams and external partners.
Qualify, audit, and monitor raw material suppliers, packaging vendors, and contract manufacturers.
Establish supplier quality agreements and performance scorecards.
Conduct routine GMP audits (domestic and international) and ensure corrective actions are implemented.
Verify raw material and packaging component specifications are consistently met.
Ensure Certificates of Analysis (COAs) are reviewed and verified.
Define in process testing requirements for contract manufacturers.
Review batch records for accuracy and completeness.
Monitor critical quality attributes (CQAs) and critical process parameters (CPPs).
Review batch documentation and approve finished product testing results prior to release.
Establish bulk review and retain sample program.
Monitor product performance and quality trends post-launch.
Oversee third party testing laboratories and ensure validated methods are used.
Ensure stability, microbiological, and preservative efficacy testing meet regulatory and brand standards; serving as primary liaison for the execution of method validation and micro-suitability.
Review and sign off on SPF testing results in partnership with Regulatory.
Evaluate and approve test methods and specifications.
Implement and manage document control systems (SOPs, specifications, batch records).
Own product documentation, including but not limited to analytical, efficacy, safety, and OTC drug stability performed by third party manufactures and labs. Track reporting dates and keep internal teams apprised of results. Assist with quality investigations related to COAs and batch records.
Collaborate with Regulatory on NHP/DIN registrations in Canada by supplying mandatory quality related documents.
Interface with international consultants (e.g.: Canadian consultant) and provide all necessary documentation to ensure goods are imported and released without delay.
Lead change control processes for formulations, packaging, suppliers, and manufacturing processes.
Ensure appropriate risk assessments (FMEA or equivalent) are conducted prior to implementation.
Prepare and review APQR reports for products distributed internationally (e.g.: Canada). Collaborate with contract manufacturers for reports and data associated with the review period.
Establish and manage deviation, investigation, and CAPA systems.
Conduct root cause analyses and implement preventive measures.
Track and trend quality events to proactively identify systemic risks.
Develop and manage GMP and quality training programs for internal teams.
Provide guidance to cross functional teams on quality requirements and best practices.
Support complaint handling processes and adverse event reporting.
Conduct complaint trend analysis and escalate systemic risks.
Lead product recall readiness planning and mock recall exercises.
Support post-market quality monitoring and continuous improvement initiatives.
Partner with R&D during formula development to ensure scalable, compliant manufacturing.
Collaborate with Supply Chain to mitigate quality risks in sourcing and production upon establishing a direct sourcing model.
Provide quality input in stage-gate product development processes.