Manager,External Manufacturing QA

Founded in 2000, Tris Pharma, Inc. (www.trispharma.com) is the 3rd largest specialty pharmaceutical company in the United States. With our intense focus on the application of physical chemistry in biological systems, coupled with the requirements of manufacturing and market demands, we have grown our employee base over 250% in the past three years. Specifically, we are engaged in research, development, and manufacturing of both OTC and Rx branded products and specialty generic products. Our mission is to understand the science driving the delivery of drugs into the human body; develop and bring to market products that add value to our customers and patients and provide a benefit to our company, employees and society at large. To support our expectations of continued growth Tris is expanding the Quality team at our Monmouth Junction, NJ facility and has an opening for an experienced External Manufacturing Quality Assurance Manager. 

This position requires 25 - 50% (domestic and international) travel.

The External Manufacturing Quality Assurance Manager (EMQA Manager) is responsible for managing the EMQA program for the company. The incumbent is responsible for maintaining the quality relationships with partners and vendors to ensure that our suppliers are qualified and using established procedures in current Good Manufacturing Practices (cGMP) environments. This includes, but is not limited to, creating, maintaining, and managing an annual external (partner/vendor) audit schedule and ensuring approved Quality Agreements are in-place.

ESSENTIAL FUNCTIONS 

Primary duties/responsibilities

• Manages the Supplier Qualification program including, but not limited to: conducting external audits, including issuing of audit reports and conducting follow-ups as appropriate, etc. 

• Maintains the Quality Agreements program including, but not limited to: negotiating, approving, executing, and maintaining Quality Agreements with customers, partners, suppliers etc. 

• Ensures the quality of batches produced by outside contract facility (Contract Manufacturing Organization (CMO) or Partner for which Tris is the importer and/or distributor), as applicable to established Quality Agreements, to assure that no errors have occurred, or if errors have occurred, that they have been properly investigated

• Manages the internal audit program and assists in conducting internal audits and GEMBA walks, as needed 

• Manages the GMP Intelligence Program

• Participates in conducting due diligence for prospective new partners

• Provides support during Regulatory Agency inspections (i.e. FDA) and customer audits, when required

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

· Bachelors degree AND minimum 5 years external quality assurance and compliance auditing experience in the pharmaceutical/biotechnology industry OR a combination of education and quality and/or compliance auditing experience in the pharmaceutical/biotechnology industry.

• Expert knowledge of cGMPs in the pharmaceutical industry and application of good documentation practices within pharmaceutical industry

• Experience working with external partners in a quality assurance capacity

• Pharmaceutical cGMP auditing experience

• Familiarity with the manufacturing and packaging process of solid oral dosage and liquid drug products

Travel requirements

25 - 50% (domestic and international) 

Physical requirements

Mainly an office-based position, but conducting production plant and laboratory walk-throughs are required

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.