Overview
We are seeking a dynamic and detail-oriented Quality Manager to lead manufacturing quality initiatives within our production environment. This pivotal role oversees all Quality Assurance (QA) and Quality Control (QC) operations. They ensure products consistently meet safety, efficacy, and regulatory standards (following cGMP, MoCRA and ISO 22716), managing compliance audits, product testing, and continuous quality improvement across all aspects of operations from incoming materials to outgoing finished goods. Quality is a proactive program – ensure that policies and procedures are in place to prevent defects with a focus on processes used to make the product. Join us to make a tangible impact on product integrity and operational excellence!

Essential Duties and Responsibilities

• Regulatory Compliance: Ensure all production and testing processes align with cGMP, MoCRA, and ISO 22716 and maintain proper documentation of all system activities.
• Quality Management Systems (QMS): Help develop, implement, and maintain robust QMS protocols. Handle document control, calibration of equipment, and change management. Improve the development of processes to improve product quality.
• Testing & Release: Oversee the inspection of incoming raw materials, in-process goods, and final finished products. Authority to place holds on or release batches and finished goods based on specification adherence.
• CAPA & Root Cause Analysis: Lead investigations into deviations, out-of-specifications (OOS) results, and customer complaints to drive Corrective and Preventive Actions.
• Supplier Quality: Work collaboratively with the supply chain team to audit and evaluate raw material vendors.
• Team Leadership and Cross-functional Collaboration: Manage, train, and mentor QA/QC personnel, Quality Supervisors, and ability to seamlessly work with R&D, operations, regulatory affairs, and purchasing departments.
• Decision-Making Authority: Must possess the confidence and authority to halt manufacturing or stop product release if quality is compromised.

Direct Responsibilities

• The test and release of all in-process products, raw materials, and finished goods for internal use or shipment to the customer
• Maintaining all the programs and documentation required when the company is audited.
• Creation of all Production Filling master documents.
• Using proper change control procedures when changing master documents with proper history maintained throughout. All records will be maintained in the master files.
• Work directly with customer service or the customer as needed to establish their specifications and requirements.
• Ensure that all customer requirements are documented in master records so that the production floor has all instructions required to produce the product accordingly.
• All documents and processes will be created as part of the quality system.
• Manage all incoming, in-process and Finished Goods sampling and testing programs.
• Assisting with customer complaints, investigations, and follow up as needed.
• SOP auditing for adherence to policy.
• Internal Facility auditing for compliance and cGMP.
• Internal GMP auditing includes reporting results and tracking corrections.
• Manage the Pest Control program to ensure service is performed correctly. Notify operations of any deficiencies or blocked traps and document correction for next Pest Control visit. There should be no repeat occurrences.
• Qualify and monitor all external labs for compliance.
• Review of Calibration receipts to ensure service was performed. Audit to ensure all labeling placed on equipment by calibration service is accurate and matches SOP requirements.
• Perform or oversee the performance of all water system testing and monitoring.
• Audit water system maintenance to ensure service was performed and within parameters.
• Initiate and carry out OOS and Non-Conformance investigations.
• Implement CAPA as needed and follow up to ensure preventative action is in place and adequate.
• Update and manage the Environmental Monitoring program.
• Annual product review completion for OTC /Medical Device products.
• Monitor and execute Training programs for Plantwide compliance and personnel development.
• Actively pursue continuous improvement of policies and procedures.
• Attention to detail - keen eye for reviewing batch records, testing data, and specifications.
• Other duties will be assigned as needed.

Management Responsibilities: Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include planning, assigning, and directing work; addressing complaints and resolving problems.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience: Five or more years of progressive quality leadership experience within the cosmetics, personal care, or topical OTC manufacturing space, preferably with strong formulations and product ingredient background. Experience with Contract Manufacturing a plus. Bachelor’s degree in chemistry, biology, chemical engineering, or a related scientific field is strongly preferred.

Pay: From $100,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Application Question(s):

• What does a strong quality culture mean to you?
• Do you have experience in cosmetic/OTC manufacturing? Please explain.

Work Location: In person