This position is responsible for administering Quality and Regulatory systems with oversight of laboratories activities, assuring that products are manufactured and distributed in compliance with cGMP, USP, USDA and FDA guidelines.

The position develops the overall approach to planning, execution and integration of Regulatory an Lab quality and supervises staff to ensure consumer safety and product quality in compliance with regulations while meeting business needs in the most efficient manner.

Responsibilities:

· Develop, Optimize and Improve Routine QC Testing operations within the APS Bio and Labella testing Labs.

· Data Reporting and Analysis to support the business function.

· Develop and Deploy Capability and Reproducibility Studies for Current Methodologies

· Improve Method Development activities amongst the market and internalize new methods within the field for testing.

· Manage all Laboratory testing Operations including internal and 3rd party testing

· Implement and Deploy Stability Testing programs for Supplement products according to standards.

· Develop a Laboratory Master plan for the improvement of Lab Operations and execute

· Manage all regulatory and quality activities for the company with the FDA, International and state regulatory bodies in ensuring regulatory compliance in support of the manufacture and distribution of products.

· Complete establishment and product listings with FDA. Ensure preparedness for FDA and third-party inspections.

· Lead all 3rd Party Certification efforts as determined by the company in accordance with business strategy and products, including SQF, ISO or FSSC

· Develop, implement, and maintain quality systems, policies, and procedures of the company.

· Manage processes to detect, document and execute opportunities for quality improvement.

· Provide leadership in the development of regulatory strategies for development of new products or modifications of products consistent with business objectives.

· Develop and maintain compliance with adverse event reporting requirements and customer contact systems.

· Closely interact with all facets of the company's business.

· Apply judgement regarding quality issues and make recommendations based on Annual and routine product reviews.

· Ensure completion of departmental tasks and projects and actively gather staff feedback and perspective

· Manage and participate in human resources/organizational development process and recruitment of key Regulatory and Quality personnel (includes staffing, employee relations, employee and organizational development).

· Ensure budgets, schedules, staffing, performance, and safety requirements are met.

· Effective management of all Lab direct reports.

Job Requirements

· Minimum 10+ years of experience in the Quality and Lab/Regulatory

· Minimum BS in Chemistry, Microbiology or related science field. Graduate level degree is a plus.

· Experience in managing a multi-disciplined compliance organization, including quality management experience

· Experience should include 5+ years of management experience with direct reports

· Ability to integrate regulatory and quality expertise with business objectives

· Ability to translate company's corporate goals into project plans

· Ability to effectively communicate, coordinate and interact with upper management, managers, and personnel within other departments

· Skilled at fully understanding scientific, medical, and manufacturing disciplines

· Thorough understanding of US regulatory requirements and standards for development, validation, manufacture, marketing, and distribution of products

· Proven track record of success and a broad understanding of global regulatory affairs and quality management requirements

· Proven track record of successful cooperative working relationships with the FDA and/or global regulatory agencies

· Progressive view of regulatory compliance and quality management and the contribution of both in a successful business strategy

· An effective leader, strong leadership, management, and mentoring skills, team-oriented

Job Type: Full-time

Pay: $100,000.00 - $140,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Paid time off
• Parental leave
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Phoenix, AZ 85004: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Regulatory reporting: 10 years (Required)
• Industrial laboratory: 10 years (Required)
• Management: 5 years (Required)

Work Location: In person

Please Note :
epokagency.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, epokagency.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.