Position Summary

Oversee the day-to-day functions of the Notice of Event (NOE) system within a cosmetic/OTC drug manufacturing facility. Responsible for documenting, reviewing, and facilitating root cause analysis investigations associated with the production of OTC drug products. This role will assist in the development, improvement, and implementation of the organization’s Quality Systems under the direction of Quality Management and will work closely with Operations, R&I, Quality, and Commercialization team members in the development and execution of NOEs and CAPAs against a timeline. Will train other teams on NOE documentation and root cause analysis; and must have a good knowledge of general manufacturing processes. The Quality Improvement Manager oversees the day-to-day functions of the BMSC Audit program and is responsible for facilitating, documenting, and reviewing both internal and external audits of the facility to ensure standards are maintained and product integrity is preserved, as well as develop and conduct internal quality audits throughout the organization based on cGMPs and FDA guidelines. It will work closely with all internal departments in the development of corrective action plans as they relate to audit findings. Additionally, this role will monitor action plans to ensure timely completion.

Responsibilities and Essential Duties

• Act as administrator of the NOE and CAPA systems to ensure a timely and compliant closure.

• Conduct or help facilitate investigations of undesirable trends in production process performance and unplanned events by performing root cause analysis and developing/implementing effective CAPAs.

• Act as administrator of the BMSC Audit program to ensure the facility operates per cGMPs and FDA guidelines.

• Ensure a timely and compliant closure to audit action items.

• Support external audits by facilitating front room audit activities.

• Improve existing Quality Systems and develop new quality processes through implementing associated procedures and other documentation.

• Provide technical support for improvement initiatives of product and process capability based on company and customer metrics.

• Review, develop, revise, and approve quality-related documents as needed.

Technical Skills Required

• Must possess strong technical skills. Certification by ASQ as a CQE, CRE, or SSGB is strongly preferred.

• Must have current knowledge of FDA regulations and Good Manufacturing Practice (GMP) regulations, as well as excellent decision-making skills in order to make risk assessments and determine the most efficient utilization of resources to accomplish departmental objectives.

• Be able to support change management; leadership skills are required in order to interface with all levels of management and to coach, train, and motivate technical staff.

• Must be able to communicate clearly, orally and in writing, and exchange information accurately.

• Must possess excellent project management skills in order to coordinate multiple projects and adhere to tight timelines while working with people at all levels of the organization.

• Must be self-motivated and possess strong problem-solving and critical thinking skills.

• Must have excellent interpersonal and leadership skills in order to effectively meet objectives.

• Must possess proficient computer skills, including Microsoft Office software (Word, Excel, PowerPoint).

Experience Required

• Bachelor’s degree or equivalent experience.

• Minimum 2 years in root cause analysis and CAPA development/implementation.

• Experience in FMCG environment (Cosmetic, Food, or Pharmaceutical).

• Experience with requirements for Cosmetic and OTC products in line with cGMP and FDA CFR 21 Part 210/211 procedures, as well as knowledge of Safety and OSHA regulations.

Physical Requirements

• Must be able to climb stairs, stand for long periods of time and have the ability to bend.

• Move, transport, and position up to 25 pounds.

• Move about inside the office to access file cabinets, office machinery, etc.