Quality Assurance Manager, Market Ready Solutions, Schenectady, NY (USA)

 

 

Quality Assurance Manager, Market Ready Solutions

 Schenectady, NY 

Hybrid, Monday – Friday

Annual Salary Range – $94,000 - $118,000

 

 

The salary or hourly wage scale provided reflects the pay range DSM expects to pay the successful candidate for the position.  Individual pay offered will be based on the applicant’s job-related skills, experience, relevant education, or training, and primary work location. This position is also eligible for bonuses and benefits, which are not included in the pay scale provided.   

Salary MIN – MID 

 

As a Quality Assurance Manager of Market Ready Solutions, you will ensure that the products produced for DNP NA (dsm-firmenich Nutritional Products, North America) are compliant with regulations and company policies. You will also ensure that the corresponding supply chain processes (Including purchasing, tolling, manufacturing, and distribution processes) meet the applicable GMP requirements regarding product safety. In this role you will also develop and implement QMS processes, SOPs, and product documentation to support DNP activities. You will provide technical expertise and serve as an expert to the organization regarding dietary supplements, dietary ingredients, OTC, and food products. A major part of this requires strong partnerships with third party contract manufacturers (3PMs) and any issues which arise during the manufacture or packaging of products for DNP are addressed and rectified in a cGMP compliant manner.

 

At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting to our People, Customers & Communities and driving business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.

 

 Responsibilities:

• Lead a team of Direct Reports and ensure that systems are in place supporting product release or rejection decisions of dietary supplements and applicable OTC products, in full compliance with applicable cGMP rules, regulatory, legal requirements and customer agreements.
• Provide support and leadership to the Market Ready Solutions team. Manage quality issues between all involved players, such as commercial management, supply chain, purchasing, regulatory affairs, 3PM, 3PL, business group quality unit, and customers. Enforce implementation of applicable management directives, ISO 9001, and GMP guidelines (as deemed necessary).
• Supervise and approve the investigations of customer and supplier complaints and adverse events, and when appropriate provides, customer-oriented answers within the given time frame. Support customer inquiries and provide quality related guidance for new and existing product formats.
• Oversee the quality change management process in TrackWise for any changes which impact product quality. For global changes, cooperate with Global Acceptance Committee. Ensure adherence and overall compliance with Quality requirements as outlined in ISO9001.
• Maintain and lead 3rd Party Certifications (UL & ISO9001) & support 3PMs with certification accordingly. Ensure qualification or periodic requalification of 3PMs and 3PLs producing dietary supplement products if completed and that quality agreements are approved. Serve as gatekeeper for new 3PM and product formats to ensure that they will be produced of the highest quality.
• Manage and communicate MRS NA Quality Policy to ensure safe, high-quality products are produced within approved contract manufacturing network.
• Perform internal and external audits and inspections to satisfy customers, authorities, and to support operational improvements. Also develop Quality KPIs.