Quality Director
Location: Torrance, CA
Salary range is $115,000-$175,000Who we are:We’re Prime Matter Labs, a personal care product manufacturer with over 40 years of experience formulating, compounding, and filling products for some of the most successful and respected brands in the world.We exist to bring better products to the world by empowering our customers to bring their ideas to life. We strive to be their most valuable partner, delivering a level of efficiency, service, and support unmatched in the industry.We’ve embarked on a bold new vision to be the leading product development and production partner in the country for emerging and established brands.
To realize that vision, we’re investing at an unprecedented level in new technology, processes, and plans that will completely rethink the way that brand’s view and interact with their manufacturer. We’re building the platform that will allow us to serve as the foundation of our customer’s branded products, from their first sample to their million-unit product run, and every step in between.Come help us build the future of the personal care and beauty landscape, one partnership at a time.What we’re looking for:We’re searching for team members to help envision, build, and execute the growth strategy of the company.
We’re looking to add ambitious leaders with an impressive track record of overdelivering on goals and expectations.How you’ll fit in:As a leader of our Quality team at PML, you will help shape and maintain the company Quality policies and manage the Company's Quality program, including the interface with customers, other departments, and regulatory agencies. This position will report directly to our Chief Science Officer.What you’ll do:•Build and lead world class Quality teams across all PML sites.•Create a culture of internal cross-functional partnership and collaboration.•Create and maintain robust Microbiology and Analytical programs.•Define and implement the quality road map for the by establishing a clear vision for the implementation of quality systems (document management, product release, investigations, etc.) and product lifecycle methodologies.•Provide technical support and oversight for analytical methods development, product, formulation and process development, and manufacturing.•Own all product investigations, lot release, material controls, R&D Quality, and data integrity processes.•Identify opportunities for process improvements, operational efficiencies, and lead implementation efforts.•Establish meaningful metrics and KPIs across sites for continued improvement and provide reports to the PML executive lead team.•Support equipment, systems, and process validation activities, including review of equipment qualification documents, drafting user requirements, and participating in impact assessments.•Be the expert on cGMP requirements, definitions, specifications, design reviews, risk assessments, verifications, and change management.•Learn, develop, and improve Prime Matter Labs’ robust library of SOP, STP, and cGMP programs.•Lead your organization in an annual goal setting and performance review process.•Act as the internal and external subject matter expert and point of contact for all Quality communication and decision making at PML.•Manage and implement Standard Operating Procedures that comply with all regulatory and cGMP requirements.•Lead the team that owns the release of Raw Materials, Component Parts, and Finished Goods in accordance with SOP's.•Oversee and evaluate all annual product reviews of OTCs.•Oversee and evaluate deviations and OOSs for continuous improvement of our production and quality processes.•Manage all customer qualification surveys, audits, and continuous improvement programs.•Develop and implement a robust external stakeholder strategy to ensure ongoing communication and collaboration with the FDA, EPA, ATF, and other regulatory agencies.•Lead all FDA and customer audits at PML West and PML Miami and guide team on internal and external follow up reports.•Establish Quality and Regulatory agreements with all customers and negotiate special requests.•Travel to and from Miami as needed to successfully oversee the team.What you have:●10+ years’ experience working in an OTC Quality leadership role.●Experience leading QA/QC teams in a contract manufacturing environment.●Track record of successful FDA and customer audits.●Impressive interpersonal and communication skills in small and large groups.●An interest in the role that new technology can play in Quality Assurance.●The ability to make tough decisions quickly, and to take ownership over the outcome.●A passion for building teams, processes, and programs that are best in class.●A history of leading organizations that are engaged and accountable.●The drive to ensure industry leading quality standards while enabling rapid business growth.●A Bachelor’s degree in chemistry, regulatory affairs or related field.●Preferred: A Master’s degree in chemistry, regulatory affairs or related field.What we’re offering:●Competitive compensation package.●Health, dental, and vision benefits.●401K program.●The spirit of a startup with the security of an established, profitable industry leader.●The opportunity to make waves in a $250B industry.At Prime, we believe that a diverse, equitable and inclusive workplace makes us a more relevant, more competitive, and more resilient company.
We welcome people from all backgrounds, ethnicities, cultures, and experiences. Prime is an equal opportunity employer.