Sr. Manager, Quality Control

Description

Position Summary

The Sr. Manager, Quality Control, will report to the VP, QC/Regulatory and help provide leadership and management direction for all quality control activities on a domestic and international level across all Markwins brands. This person will have oversight management responsibilities to include Microbiology, Analytical Chemistry, Quality Control, Inspection, Quality Assurance, and Validation. The Sr. Manager, Quality Control will work closely with cross-functional teams to ensure all Markwins’ products meet high-quality standards and are ready for sale or distribution.

Essential Tasks, Duties, & Responsibilities

• Work with the VP, QC & Regulatory to oversee the Quality Control teams ensuring that all laboratory operations support the manufacturing operations and Markwins business objectives, and that the laboratory operations comply with all the laws, regulations, and guidance applicable to pharmaceutical drug manufacturing
• Interacts with production management to ensure quality systems are being followed in the manufacturing areas
• Formulate and maintain quality control objectives and coordinate objectives with production procedures in cooperation with other managers to maximize quality and reliability and to minimize costs
• Oversees the daily functions of all quality laboratories
• Oversees reviews and approvals of documentation generated by the labs
• Ensure all documents are kept current and revised as needed
• Create any needed SOPs and review, correct, and improve upon any current SOPs
• Manage and oversee all compliance issues including validation, calibration, etc.
• Regulate routine audits of manufacturing areas, laboratories, quality systems, etc. and generate a written report outlining recommendations
• Collaborate with third-party labs to carry out product safety and efficacy testing for both cosmetics and children’s products testing (CPSIA) while remaining within budget and timeline
• Conduct audits of suppliers and third-party laboratories in compliance with FDA cGMP and ISO 22716
• Work in conjunction with other departments manage customer complaints including tracking and close-outs as required by FDA for both OTC and cosmetic products
• Ability to conduct and manage mock and official product recalls
• Interacts with visiting regulatory bodies as needed
• Oversees training program for all employees and maintain related documentation
• Be able to comprehend Markwins’ environment of fast production and the need for urgency to get things done without compromising the quality of the product
• Regular monthly travel to Mexico facility with stays from overnight up to a week; travel abroad other than Mexico may be required but will be less frequent
• Perform other duties as needed and directed by management

Qualifications

Minimum Qualifications

Education & Experience

• Minimum of bachelor’s degree in Chemistry or other science disciplines
• 10-12 years of experience in QC/QA preferably in a cosmetic or personal care products company; additional experience in regulatory is a plus
• 5-7 years of related supervisory/management experience to include building and developing teams
• Must have 5-7 years’ experience as an active participant with cosmetic-centric FDA audits
• Must be a practitioner of and have a solid understanding of regulations surrounding cosmetics including US-FDA, FPLA (Fair Packaging and Labeling Act), FDC (Food, Drug, & Cosmetic Act), EU Cosmetic Regulation 1223/2009, and Health Canada
• Familiarity with notification streams including US & Canada OTC’s, Health Canada CNF, and EU CPNP is beneficial

Knowledge, Skills, & Abilities

• Ability and availability to travel to Mexico facility monthly from 1-5 days; travel abroad other than Mexico may be required
• Strong leadership in establishing work priorities for multiple projects, accepting responsibility, developing confidence & respect, and shifting priorities to accommodate change
• Clear, concise, and effective written and verbal communication with customers and staff is critical
• Ability to demonstrate accuracy and thoroughness, looking for ways to improve and promote quality
• Considerable management skills are required to successfully perform the responsibilities of this position
• Strong attention to detail and impeccable organizational skills
• Strong planning and analytical skills with demonstrated business impact in previous roles
• Collaborative working style, ability to foster effective working relationships within a team environment
• Demonstrated proficiency in MS Office Suite

Note: The statements herein are intended to describe the general nature and level of work being performed by employees, but are not a complete list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the employer.

Markwins Beauty Brands is an Equal Opportunity Employer

Markwins Beauty Brands does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age, sex, gender, sexual orientation, marital status, veteran status, disability, or any other proscribed category set forth in federal or state regulations.