Director of Quality (Nutraceuticals)
Jobot San Francisco, CA
- Posted: over a month ago
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
A bit about us:
Our client is dedicated to helping families grow with safe and effective products that provide relief from many of the common health challenges families face.
Why join us?
100% paid for employee health insurance
Company Paid Vacation
Excellent family leave programs
The Director of Quality will play a key role in defining, establishing new, and enforcing the quality systems currently in place with an eye for future business needs. This role exists to ensure safe and effective products for our customers.
The Director of Quality will be responsible for ensuring appropriate methods are strategically integrated into the broader company goals, taking long- and short-term views on product quality as products, processes, and company priorities evolve. Additional primary duties include compliance with GMP's and testing best practices, coordination with QA, R&D, and Regulatory Affairs for specifications ensuring the identity, purity, strength, potency, and composition of personal care, dietary supplement, and OTC drugs. This role will lead, mentor, and develop our quality management team. The ideal candidate is eager to take on new challenges and is willing to identify areas for improvement.
As Director of Quality, the position will be expected to protect the brand through continuous improvement in the areas of compliance to safety, quality, regulatory, and corporate standards. This includes participating in the innovation process to ensure complete quality and product safety risk analysis and validation of compliance documentation.
Reports to: Sr. Director of R&D
· Lead the Quality Assurance and Quality Control teams and work in concert with the R&D Director. The Quality team is responsible for all supplier and product quality programs spanning across innovation and ongoing business.
· Oversee multiple direct reports responsible for supplier qualification, QA Agreements, nonconformance program, quality investigations, organic and NSF certifications, product specification control, artwork review, receipt inspection and more.
· Support the company in assuring regulatory compliance.
· Solicits participation from team for the setting of goals and improvement measures.
· Oversees product and material stability testing programs.
· Contributes to new formula review and approval with R&D and Regulatory with focus on transitioning to ongoing quality management over time.
· Acts as a subject matter expert on behalf of the organization for quality and day-to-day product safety issues.
· Foster a collaborative relationship among other functional areas (operations, sales, marketing, R&D, etc.), this person will maintain the status as the conduit between the QA team and Leadership on quality assurance, product safety and regulatory affairs.
· Leads a staff that is results oriented and driven while developing and implementing regulatory strategy and managing those systems and programs to meet all company goals and objectives.
· Demonstrable ability to manage both external and internal relationships, inspection regimens, post-market compliance plans, adverse event reporting, and label approval processes.
· Provides technical guidance in problem resolution where OOS instances occur.
· Coach team on quality and operational process evaluation for improvements. Recommend and support projects for improvements to product quality.
· Lead team in communicating significant issues or developments identified during quality assurance activities, assisting in implementing corrective actions where necessary. Participate in co-manufacturer performance scorecard and set KPI’s target to drive their continuous improvement.
· Lead quality assurance team systems to insure accurate and appropriate responses to consumer complaints oftentimes requiring direction communication to consumers.
· 10+ years’ experience in supplement or OTC drug manufacturing with at least three years in a senior role (Manager or above).
· Experience with ISO 22716; NSF / ANSI Dietary Supplements; 21 CFR 111; 21 CFR 11; ICH 8, 9, 10, strongly preferred.
· Excellent people management skills as well as experience in the management of quality systems and technical services functions.
· Ability to set challenging, reasonable performance expectations for regulatory compliance as well as microbiological and chemical standards,
· Experience and working knowledge of continuous improvement processes as well as the ability to effectively collaborate with company senior leadership at suppliers and customers
· Working knowledge of all relevant cGMP’s, HACCP, FDA and CFR regulations as they pertain to dietary supplements or OTC medication.
· Working knowledge of relevant certifications in ISO, NSF, or other certifying bodies
· A deeply technical background that can easily translate evidence into action
· A collaborative nature that works well independently and with others
· A willingness to work with teammates to build a healthy professional environment to produce effective, safe, and quality products
· Periodic travel may be required. Must have or be able to obtain a passport that allows international travel.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
AddressSan Francisco, CA