Quality And Regulatory Manager Nutraceuticals

Pharmachem Laboratories LLC

Are you the kind of person that is always thinking, sketching, seeking, and adjusting? Who needs to understand how things work and then figure out how they can work better? Are you a passionate, tenacious, solver who loves to work with others who share your drive? Are you positive, constructive, and ingenious?

Are you always solving?

Then we’d like to meet you and bet you’d like to meet us.

Ashland’s Quality and Regulatory Affairs team applies scientific knowledge and Regulatory expertise to develop responsible and sustainable strategies for opening doors to new market opportunities while complying with applicable legislation, mitigating risk to human health, and by advocating to create a competitive advantage for our businesses. We provide practical interpretations for implementation and comprehensive regulatory compliance solutions for our customers to complex problems in today’s evolving regulatory landscape —we are, always solving™.

This position is responsible for leading the Quality and Regulatory affairs programs supporting global dietary ingredient and supplement commercial activities and their related operations. The position requires collaboration with regional product regulatory staff, business partners and internal stakeholders from various functional groups. In addition to providing governance and interpretation for regulatory requirements internally, the position represents Ashland externally to customers, regulatory authorities and trade organizations.

This position is also responsible for supporting quality activities regarding the safety, consistency, and quality of our products, this includes developing, implementing and maintaining quality programs, policies and procedures to improve product Quality and ensure products are produced in compliance with product standards, good manufacturing practices and in accordance with government regulations. In addition, this role will be required to interact with both internal and external customers, as well as Quality and Regulatory agencies.

Ashland has an exciting opportunity for a Quality and Regulatory Manager, Nutraceuticals to join our Ashland Nutraceutical business at either our Kearny, NJ or Ogden, UT. This is a very visible, significant role within the Company and the Quality and Regulatory function. This position will report to Life Sciences Global Director Quality and Regulatory

The responsibilities of the position include, but are not limited to, the following:

• Develops, implements, monitors, and continuously improves programs to ensure compliance with industry standards for food and dietary supplements (cGMP, 21 CFR  111, 117, HACCP, FSMA, SQF, etc.)
• Supports customer & other regulatory agency audits & escalates any quality control and food safety issues and presents plausible solutions
• Supports Facility Audit Program to help assure compliance to internal/external requirements, including customer requirements and strategic initiatives.
• Ensures timely resolution to customer inquiries (audit findings and complaints)
• Generate, review or approve Quality Assurance related documentation required for customer relationship/product development (such as: development, supply and quality agreement), verification of compliance, or for filings with regulatory bodies.
• Organize and ensure the completion of all product investigations, Non-Conformances, OOS’s, and CAPAs
• Responsible for HACCP plan and any related quality related risk assessments
• Navigate the people and processes of our commercial, manufacturing and supply chain organizations as well as the external landscape of regulatory agencies and industry groups to advocate on behalf of Ashland
• Monitor for changes in regulatory strategy at relevant agencies/authorities to identify potential impact to Ashland food and dietary supplement business segments from emerging regulatory issues
• Interpret legislation and devise solutions to comply, mitigate unacceptable risk and create a competitive advantage for Ashland’s businesses
• Actively contribute to the organizational goals by taking initiative, executing on goals and focusing on performance and safety
• Improve the organization capacity and capabilities through building collaborative relationships, optimizing diverse talent and utilizing positive communications and influence with others

Enable Innovation and Sales

• Represent Product Regulatory to business leadership of the Nutraceuticals business segment to develop regulatory goals and objectives in alignment with business strategy
• Conduct global regulatory reviews on formulations and compliance analysis for destination countries as a part of Ashland’s New Product Introduction (NPI) process for commercializing new products
• Prepare and submit product regulatory registrations to relevant agencies/authorities/organizations as required to support sales and marketing in targeted geography and end-use application
• Engage directly with customers to support their regulatory activities relevant to qualifying and / or registering Ashland supplied ingredients
• Develop standard product regulatory statements to provide efficient indirect support to customers on frequently requested regulatory topics

Governance and Continual Improvement

• Lead with the courage and confidence to guide the company towards innovative solutions that leverage a risk-based approach yet deliver ethical decisions and products that are safe, suitable and compliant for their end-use markets
• Monitor regulatory activity and assess business impact to identify non-compliance issues or risks
• Engage and collaborate with internal and external legal counsel on matters of non-compliance
• Recommend and implement management programs and processes, including practices to support regulatory compliance and risk management activities
• Monitor program effectiveness and continually improve performance

In order to be qualified for this role, you must possess the following:

• Bachelor Degree in chemistry, toxicology, biology or other science discipline
• Thorough knowledge of product regulations, enforcement and industry practice relevant to the food and dietary supplement industries
• 5 - 7 years of Product Regulatory relevant experience working with regulatory agencies such as US FDA and trade organizations such as the Council for Responsible Nutrition, Untied Natural Products Alliance, Consumer Healthcare Products Association or other relevant organizations
• Fast learner with a flexible style and the ability to adjust to changing business priorities and changing regulatory landscapes
• Demonstrated responsible and ethical behavior at all times
• Drive greater value through understanding the business, making complex decisions and creating the new and different
• Ability to interface with internal and external contacts at all levels
• Experience to lead international projects, programs and virtual teams

The following skill sets are preferred by the business unit:

• Master Degree, in chemistry, toxicology, biology or other science discipline
• Professional regulatory certification

Perks of working at Ashland:

• Team recognition rewards, sponsored lunches and monetary incentives based on performance
• Comprehensive Benefit package, Medical, Dental and Vision starting on Day 1 for you AND your family
• 401(k) plan with company match
• Referral bonus plan – get a job with us and get paid to refer your friends

In more than 100 countries, the people of Ashland LLC. (NYSE: ASH) provide the specialty chemicals, technologies and insights to help customers create new and improved products for today and sustainable solutions for tomorrow. Our chemistry is at work every day in a wide variety of markets and applications, including architectural coatings, automotive, construction, energy, personal care and pharmaceutical. Visit www.ashland.com to see the innovations we offer.
 
At Ashland our vision is to be a leading, global specialty chemicals company whose inspired and engaged employees add value to all we touch. In fact our people, employees, customers and vendors define who we are. They are the driving force behind everything we do.
 
Not only do we value our customers but we value our employees, and we work to offer them a dynamic and challenging environment. We hold ourselves to high standards at Ashland, and we value integrity and honesty.
 
Ashland has a history of attracting the best people and keeping them. The reasons are simple: industry competitive salary and benefits, pay-for-performance incentive plans and a diverse work environment where employees feel challenged and valued. People come to Ashland and stay. As a growing Fortune 500 specialty chemicals company, we offer opportunities for development and advancement throughout our global organization. Our values define who we are and what we care about as a company. If you are looking for a relationship with a company instead of simply a job, this may be a great fit.

Ashland is proud to be an Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Gender Identity/Sexual Orientation. 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability. NOTE:  We do not accept resumes from external staffing agencies or independent recruiters for any of our openings unless we have a signed recruiting agreement in place to fill a specific position.