The Product Quality Assurance Lead is a key member of the Quality Assurance team and is responsible for ensuring the cGMP compliance of Quality Systems, Quality Documents, SOP's, Validation reports, Change Control, non-conformance, document control, and supporting the eQMS system development, validation, and launch activities. Overall, the Product Quality Assurance Lead is responsible for Quality Assurance support and ensuring Rodan + Fields is in compliance with applicable cGMP and regulatory and Federal regulations. This position will support all aspects of Product Quality Assurance. This position reports to the Director QA/QC and is based in San Francisco.
Reports to: Director QA/QC, Quality
- Independently supports Product Quality Systems, eQMS library development and organization; eQMS validation support; UAT testing; eQMS enhancement to incorporate Supplier qualification, Regulatory & Packaging; enhancing system SOP's; Quality Metrics & KPI support.
- Receive, evaluate and review the quality and accuracy of Quality Systems and Stability/inspections related documents, analysis, and workflows.
- Work cross-functionally with Product Quality, Regulatory, Customer service, Packaging, Product Development, Stability, Veeva, and our external suppliers to ensure deliverables meet established timelines. Prioritize and coordinate the review of material based upon project urgency.
- Monitor product expiration dates of existing retain stock and annual standards to ensure the highest standards of product quality.
- Work cross-functionally to assist/support the logistics team with reporting and transactions
- Maintains the company's Product Quality and Stability processes and Quality Management Systems.
- Assists with the archiving and storage of batch production and laboratory control records.
- Help create, organize, manage and archive cGMP documentation, product release, investigation support documents, non-conformance, CAPA, and stability program.
- Track, trend, and report on Product Quality System KPIs and deliverables.
- Assist in promoting and advancing quality awareness throughout the Company through the expansion and development of the Quality Management System.
- Provide additional support to the Product QA team as determined by the Director of QA/QC.
- The Food and Drug Administration's Quality System Regulations (FDA's 21CFR 210/211, QSR, ISPE GAMP 5), Software (SaaS) validation/verification;
- Ability to read, analyze and interpret Quality data. Ability to write reports, risk assessments, business correspondence and procedure manuals/SOP's.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- A proven track record of working collaboratively and being accountable.
- The ability to effectively partner and motivate across functions and with outside vendors.
- The ability to think strategically, creatively, and analytically.
- Outstanding oral and written communication skills.
- Exceptional organizational skills and a great attention to detail.
- Self-motivator and able to drive results quickly
- Willingness to jump in to help accomplish tasks
- Ability to work with both qualitative and quantitative Quality documentation and information
- A strong desire to support and enhance our customers' product experience
- Candidate should demonstrate flexibility, be willing to wear many hats and be hands on
- Attention to detail and ability to perform a variety of Quality System related tasks
- Thrives on building effective business relationships and possesses strong follow up skills
- Must possess ability to work in a fast-paced, high-growth environment
- Working knowledge of IT cloud-based applications and Microsoft Office applications: SaaS, Word, Excel, and Outlook.
- Bachelor's Degree with a Minimum of 8 to10 years of professional experience in a corporate environment preferably in one of the following industries/disciplines: skincare, life sciences, manufacturing, quality control, food, regulatory, or clinical testing.
- Prior experience in the skincare industry, cGMP Quality Systems, or Product Quality, Validation of Software (SaaS) working knowledge preferred.
Rodan + Fields was founded in 2000 by Stanford-trained Dermatologists Dr. Katie Rodan and Dr. Kathy Fields with a passion for giving people the best skin of their lives - and the confidence that comes with it. Today, Rodan + Fields is the #1 Skincare Brand in North America  in 2018 and the #1 Skincare Brand in the US in 2016, 2017 and 2018  ! The company has grown its innovative line of products and expanded into Canada and Australia. Headquartered in San Francisco, CA, R+F now employs approximately 700 people, has more than 300,000 enrolled Independent Consultants and over two million Preferred Customers.
At Rodan + Fields, you will be challenged to make an impact, inspired to do more, and rewarded for your contributions. We are transforming skincare, and we welcome your big ideas to fuel our ambitious growth plans! If you are looking for a life-changing career opportunity, we've got your prescription. You'll become part of a positive, passionate movement that celebrates greatness and encourages employees to be catalysts for change. We provide a creative, vibrant workplace outfitted with all of the technology, tools and training you'll need to learn, grow and thrive! We create life-changing impact in our communities through our non-profit, Prescription for Change®, the heart of Rodan + Fields. By funding empowerment programs for students, we teach them how to use their skills to make life-changing differences in their lives and the lives of others. Join us and share your talents as we develop innovative solutions for your skin and empower entrepreneurs. In addition to working arm-in-arm with industry leaders, employees at Rodan + Fields enjoy rich benefits plans and perks.
 Source Euromonitor International Limited; Beauty and Personal Care 2019 Edition, retail value RSP terms; all channels, Skin Care includes Sets and Kits; North America defined as Canada and the United States  Source Euromonitor International Limited; Beauty and Personal Care 2019 Edition, retail value RSP terms; all channels, Skincare includes Sets & Kits.