Overview

The Quality Manager is responsible for developing and executing the site quality program which will enable the firm to continue to be an industry leader in production and quality of personal care products. The role is responsible for receiving, in-process and quality release activities for the site quality program including managing tactical quality teams, monitoring and releasing production/product and hosting regulatory and customer visits. The overall compliance of the site, specific to Voyant Corporate Quality, customer and/or regulatory agency requirements, is the central responsibility of this role.

The successful candidate will have a strong history of compliance system management and a strong track record of people leadership and excellent communication skills. The ability to organize, inspire and lead the diverse work group and partner with other functional groups is a critical success factor. Additionally, the ability to successfully partner with external customers while protecting Voyant Beauty's interests is key.

Individual assures that quality & regulatory affairs systems are managed, continuously reviewed and improved for compliance and operating efficiencies. Individual ensures that QA department personnel are trained, and the site training program is well integrated. In addition, the Quality Manager ensures compliance to a combination of product regulations (pharmaceutical and cosmetic product guidelines).

Role and Responsibilities

• Actively promote and drive the Quality Culture in the site
• Ensure compliance with all applicable Customer, FDA, and EMA regulations
• Provide guidance to site on quality compliance standards and expectations
• Manage the Batch Release Process: completes quality assurance operational requirements by scheduling and assigning employees and providing adequate oversight to ensure that requirements are met
• Manage the site's Fill & Assembly Specification process
• Manage the site's Customer Complaint and Internal Audit program
• Manage the site's In-Process and Incoming Inspection processes
• Manage all communications with the client and leadership team
• Provide oversite for process changes by reviewing and signing off on IQ/OQ/PQs
• Oversee and coordinate batch card changes with R&D
• Assist with review and approval of quality agreements and act as liaison with all clients on commercial quality topics
• Oversee compliant document management and retention programs
• Streamline departmental procedures and ensure staff are trained in pursuit of robust compliance and operating efficiency
• Ensure site-wide training documentation is adequately maintained and retrievable
• Author, review, and approve applicable, SOPs, WI's, Investigations, Deviations, and review of data for trends
• Manage and maintain close oversight over all compliance related activities, including evaluation of current program status
• Participate in global quality system harmonization activities
• Generate and maintain site quality system metrics
• Manage Quality Assurance staff job results by coaching, counseling, planning, monitoring, problem resolution mediation, and appraising through performance reviews against measurable objectives.
• Any other task assigned by the VP of Quality and as deemed necessary.

Qualifications and Education Requirements

• Bachelor's Degree required, preferably in chemistry, life sciences or related field
• 5+ years in quality assurance in cosmetic, drug or equivalent regulated industry
• Knowledge of cGMP/USP/CFR/GLP/FDA regulations including plant hygiene practices.
• Previous people leadership roles with multi-shift direct reports
• Progressive leadership roles within quality organizations with proven successful track record
• Strong leadership and communication skills, with demonstrated team building success and has a passion for building, developing and leading strong diverse teams
• Creative conceptual thinker with strong analytical and problem-solving skills; comfortable with technical issues
• Action driven, cooperative and flexible individual

Physical Requirements:

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position. While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility. Must be capable of using a keyboard for computer purposes.

To Staffing and Recruiting Agencies: Our company does not accept unsolicited CVs or applications from agencies. We are not responsible for any fees related to unsolicited CVs or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application.

Our company provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, color, national origin, sexual orientation, age, disability or veteran status. In addition to federal law requirements, Vee Pak complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.