Director of Quality
Our client is in search of an exceptional quality leader who thrives in a fast-paced manufacturing environment with capability to oversee all operational aspects of the business’ Quality function with a demonstrated ability to lead and motivate your team while providing a unifying vision for the entire organization.
As Director of Quality (DOQ), you will be accountable to establish maintenance, administration and continuous improvement of all aspects of cGMP Quality Operation functions, including Quality Systems, Lab Quality Control, Floor QA, Change Control, Document Control, Training, Vendor/Supplier QA. This role is a partner through all phases of manufacturing and production to assure compliance to all appropriate requirements pertaining to Good Manufacturing Practices (GMP). The position will manage quality responsibilities to support the manufacturing, testing and release of finished product under FDA/ISO regulations, standards and internal procedures. Include conducting investigations into GMP-related issues, management of the change control process, SOP preparation/revisions, GMP training programs and all other related quality systems. The DOQ is expected to develop and implement plans for continuous improvement and more effective and efficient execution of the overall activities of the Quality teams. The interaction with Manufacturing and Product Development areas will be optimized, all leading to the most consistent, high quality, products and processes. The person is required be a visible and respected leader for Quality and the entire organization. They will participate at the company mid-management level to ensure our best practices include Quality as a key element of our strategic thinking as the business grows.

Detailed Job Description
• Designs and manages quality systems that ensure optimum process and product performance
• Leads investigating and implementing corrective/preventative action for customer complaints, nonconforming products, and nonconforming systems.
• Develops and manages procedures and work instructions to ensure conformance to specifications, quality systems, safety, and good manufacturing practices.
• Maintains a close relationship with Operations and R&D to facilitate quality products, and design and achieve quality goals.
• Manages the design and implementation of quality-related training programs for QA and Operations personnel in performing required tests, decision-making skills, statistical process control, and other areas as needed. Partners with HR, Operations and R&D to design effective training curriculums to meet best practices manufacturing processes.
• Recommends and reviews changes, oversees implementation and documents any approved design changes that apply to commercial products.
• Works directly with customers to facilitate specifications, product design, quality systems, information exchange, non-conforming product, variances and investigation.
• Sets direction for audits of in-process & finished products, facility housekeeping, sanitation and pest control.
• Acts as Project Coordinator and/or Project Leader as assigned for special projects.
• Represents the Company, as directed by Sr Management, in discussions with customers, suppliers, auditors, and regulatory agencies of the county, state, and federal government (USDA, FDA, etc.).
• Establishes, prepares and manages necessary department budgets, operating and periodic reports.
• Initiates and handles personnel actions such as hires, transfers, promotions, discipline and terminations.
• Develops and implements methods, trend analysis metrics, reports and procedures, to inform management of status or work activities.
• Manage departmental performance against agreed metrics and key performance indicators
• Actively contribute to Executive Management Team policy and strategy.

Education and Experience
• Bachelor’s degree in life sciences, i.e., biology, chemistry, etc. required
• 10 years of relevant experience in Quality is required, at least 3 years of that must be in a leadership capacity
with managing direct reports
• Experience in a variety of areas within Quality Management Systems.
• Direct experience with regulatory audits, including direct interface with inspectors.
• Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development
through commercial application.
• Strong knowledge foundation of FDA regulations regarding the manufacture of cosmetics/OTC (210, 211, CFR,
ISO), including regulatory inspection or support experience is preferred.
• Capable to manage multiple priorities and maintain adherence to timelines.
• Must be able to build effective working relationships with key business partners, customers, suppliers and
peers.
• Personal Care product and process related experience required with pharma experience considered
• Key Competencies Include: Prioritization based on business value, cross functional team building,
Interpersonal and Leadership Skills
• Persuasive Written and Oral Communication, Teamwork/Collaboration and Effective Management of
Personnel

To Apply: Email resume directly to Kathy Nichols at nichols@mrbridgewater.com