Site Quality Manager
About the Company:
Voyant Beauty is a full-service partner to the personal care and beauty industry and a leading value-added manufacturer of innovative hair care, bath and body, and skin care products to both established multi-nationals and fast-growing emerging brands.
Voyant Beautyhas 7 manufacturing facilities across the USA and Poland with 3 Innovation centers located in New Jersey, Chicago and California. The company employs more than 1000 people.We are a full-service partner to the personal care and beauty industry and a leading value-added manufacturer of innovative hair care, bath and body, and skin care products to both established multi-nationals and fast-growing emerging brands.
Come join in the excitement!
The Manager of Site Quality Operations is responsible for developing and executing the New Albany, Ohio site quality strategy which will enable the firm to continue to be an industry leader in production and quality operations. The role is responsible for all elements of the site quality strategy including managing tactical quality teams, monitoring and releasing production/product, and hosting regulatory and customer visits. The overall compliance of the site, specific to customer and/or regulatory agency requirements, is the central responsibility of this role.
The successful candidate will have 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.
Function includes management and oversight of the entire site QA Department. 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 Director of Site Quality Operations ensures compliance to a combination of product regulations (pharmaceutical and cosmetic product guidelines).
- Ensure compliance with all applicable Customer, FDA, Health Canada 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 Annual Product Review (APR) program, ensuring completion according to customer requirements and schedule.
- Manage the site's Customer Complaint and Internal Audit program.
- Review and approve 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, Investigations, DEA biennial and year-end inventory numbers, etc.
- Manage and maintain close oversight over all compliance related activities, including evaluation of current program status.
- Participate in and facilitate global quality system harmonization activities.
- As a member of the External Audit Host Team, field questions and manage a controlled flow of documents and information to auditors.
- 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.
- Bachelor's Degree required
- 8+ years' in quality assurance and/or regulatory leadership
- Knowledge of cGMP/USP/CFR/GLP/FDA regulations
- Progressive leadership roles within quality organizations with proven successful track record
- Strong leadership and communication skills with demonstrated team building success. Has a passion for building, developing and leading strong diverse teams including remote locations
- Creative conceptual thinker with strong analytical and problem-solving skills; comfortable with technical issues
- Decisive with a bias to action
Robust compensation and benefits package.