A Brief OverviewThe Senior Manager of Site Quality Operations is responsible for developing and executing the site quality strategy in partnership with the site General Manager, 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 materials/product and hosting regulatory inspections and customer visits. The primary responsibility of this role is the overall compliance of the site to customer and regulatory agency requirements. The successful candidate will have a strong history of compliance system management at a manufacturing location in at least one of the following regulated industries; cosmetic, pharmaceutical, or medical device. The candidate will have a strong track record of people leadership and excellent communication skills, and the ability to organize, inspire, and lead a diverse group of employees. This candidate will be able to partner with internal functional groups and with external customers ensuring the protection of proprietary information for customers and Voyant Beauty. The Senior Manager of Site Quality Operations has oversight and manages the entire site Quality Department. This role assures that the quality & regulatory affairs systems are managed, continuously reviewed, and improved for compliance and operating efficiencies. This individual will ensure that the Quality department personnel are trained. In addition, the Senior Manager of Site Quality Operations will ensure compliance for multiple regulated product categories; aerosol, pharmaceutical/OTC, cosmetic, personal care, medical device, household (EPA regulated), and ISO standards.
What you will do- Ensure site and product compliance with all applicable customer, certifications, and regulatory agencies (e.g. FDA, Health Canada, EMA, etc.). To include the following tasks:
- Direct the 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 nonconformance, investigation, and CAPA program.
- Manage the site's external (customer) specification documentation process including the Fill & Assembly Specification process.
- Manage the site's Customer Complaint and Internal Audit program.
- Manage the site's Analytical and Microbiological laboratories and their associated testing.
- Manage the site's In-Process and Incoming Inspection processes.
- Review, comply with, and manage customer quality agreements.
- Manage the Document Control and retention programs.
- Author, review, and approve site level documents and records as required.
- Monitor compliance to the training program and ensure training records are adequately maintained and easily retrievable.
- Report status of quality system and manage risks. To include the following task:
- Report KPIs and site quality metrics to Operations, Corporate Quality, and Executive Leadership.
- Ensure continuous improvement in the quality system.
- Primary Quality Representative for customers. To include the following task:
- Act as liaison with site customers on commercial quality topics and quality issues.
- Audits. To include the following tasks:
- Host and support all Quality System audits and inspections as the Generalist (Lead Quality SME).
- Ensure all audit and inspection observations/findings are addressed in a timely and effective response.
- Responsible for the site internal audit program.
Education Qualifications- Master's Degree Science, Engineering or related field of study (Preferred)
- Bachelor's Degree Science, Engineering or related field of study (Required)
Experience Qualifications- 10+ years In quality assurance and/or regulatory leadership (Required)
- 10+ years Familiar with aerosol product manufacturing (Preferred)
- 10+ years Progressive leadership roles within quality organizations with proven successful track record (with multi-shift direct reports) (Preferred)
- 10+ years Strong leadership and communication skills with demonstrated team building success (Required)
- 10+ years Mentors as needed in and supports development opportunities for direct reports (Required)
- 10+ years Creative conceptual thinker with strong analytical and problem-solving skills; comfortable with technical issues (Required)
Skills and Abilities- Expert knowledge of regulations for Pharmaceutical/OTC, Cosmetic, and Medical Device manufacturing (e.g. cGMP, USP, 21 CFR 820, 210/211, GLP) (High proficiency)
To Staffing and Recruiting Agencies: Our company does not accept unsolicited curriculum vitae's or applications from agencies. We are not responsible for any fees related to unsolicited curriculum vitae's or applications and explicitly reserve its right to contact candidates presented in such unsolicited curriculum vitae's or application.
