Director, Quality and Compliance

Employer
Tris Pharma
Location
Monmouth Junction, NJ
Posted
Jan 16, 2022
Ref
772111
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Contract

  

Founded in 2000, Tris Pharma, Inc. (www.trispharma.com) is the 3rd largest, private, 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 continued growth Tris has an opening at our Monmouth Junction, NJ facility for a Director, Quality Compliance.

The Director, Quality Compliance provides operational leadership and support to the total Quality function to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating Procedures (SOPs), global Good Manufacturing Practices (GMPs), Food and Drug Administration (FDA) standards, relevant foreign drug regulatory standards, established specifications and drug registrations. The incumbent has direct oversight of department activities, development of personnel, and ensuring quality of deliverables within her/his purview. She/he is recognized as an expert in the principles and applications of quality compliance and serves as a decision maker and point of escalation for customer, internal, and external concerns/issues.

ESSENTIAL FUNCTIONS 

• Leads the total Quality Compliance function of the manufacturing plant and R&D. Ensures adherence to, and compliance with all SOPs, cGMP, FDA, Drug Enforcement Agency (DEA), and applicable international drug enforcement agency regulations, as well as all applicable company quality compliance guidelines, standards and objectives

• Presides over the company’s supplier qualification program to systematically evaluate suppliers based on: the risk to the quality of the product or service supplied, compliance of the supplier/partner’s quality systems to applicable regulations and requirements of the supply contract or quality agreement, the reliability of the supplier/partner to avoid quality deviations and shortages of components and/or products

• Directs External Manufacturing QA function to ensure contract manufacturing, contract packaging, contract distribution partnerships adhere to compliance with cGMP, FDA, Drug Enforcement Agency (DEA), and Occupational Health and Safety Administration (OSHA) regulations, as well as all applicable company compliance guidelines, standards and objectives

• Oversees R&D QA function to ensure that all the planned and systematic actions to verify whether R&D processes are conducted in a proper manner and the results of R&D fully satisfy Tris and cGMP requirements as appropriate

• Represents Tris during drug regulatory inspections and customer audits; Provides information as necessary to FDA and other national drug regulatory authorities that establishes credibility and demonstrates compliance with GMPs; Coordinates with drug regulatory agencies and other external auditors to build trust and confidence in the site’s quality systems; Promotes and advances quality awareness throughout the company; Participates in, and oversees, inspection readiness activities

• Runs GMP program for reporting requirements such as US FDA Field Alert Report (FAR) regulations 21 CFR 314.81 & 21 CFR 314.98 

• Controls the internal audit program for the company

• Presides over the GMP intelligence program to ensure that cGMP trends and/or regulatory changes are communicated, assessed, and have action plans implemented to ensure ongoing quality compliance of the company

• Serves as the main quality contact with all third-party partners and suppliers and works cross-functionally to establish and ensure adherence to all quality agreements

• Develops, compiles and analyzes business metrics and highlights for the Quality Compliance function 

• Manages, mentors, coaches, and develops direct reports and Quality Compliance organization

Requirements

  

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Bachelor’s degree in a Science or related field AND a minimum 12 years of experience in the pharmaceutical or biotechnology industry in quality or compliance positions of increasing technical and leadership responsibility

Special knowledge or skills needed and/or licenses or certificates required

• Expert knowledge of GMPs in the US and global pharmaceutical industry

• Excellent hands-on experience with implementing and managing Quality/Compliance systems and processes (infrastructure)

• Proven track record of successful interactions with the FDA and other health authorities 

• Experience with the execution, coordination, and tracking of Quality Management Systems (QMS) procedures and related activities

• Proven people management experience 

• Ability to influence without direct authority

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. #LI-DNI