Director, Quality Assurance

Monmouth Junction, New Jersey
Tris Pharma Inc
Description:

Tris Pharma, Inc. () is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success.

Our Quality department located in our Monmouth Junction, NJ headquarters has an immediate need for an experienced Director, QA.

The Director Quality Assurance leads and directs the activities involved in quality operations and the quality systems to ensure manufacturing and development quality controls and procedures are followed in accordance with Standard Operating Procedures (SOPs), US current Good Manufacturing Practices (cGMPs), US Food and Drug Administration (FDA) standards, and specifications. The incumbent oversees the internal batch release decision process, including the dispositioning of raw materials, components, intermediates, in-process materials, clinical supplies, and finished products. 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 assurance and serves as a decision maker and point of escalation for quality system events.

• Responsible for all material disposition decisions to ensure the quality of materials purchased, received, tested, processed, manufactured, and/or distributed by the company; Oversees disposition of commercial products to meet both company and regulatory requirements for commerce

• Directs the quality assurance functions on the operations floor, research laboratories, and warehouses including room/line releases, real time inspections and material sampling and releases

• Oversees the management of the quality systems, including but not limited to:

o quality assurance floor inspection

o raw material sampling, inspection, and release

o batch dispositioning

o investigations

o quality documentation including SOPs

o product quality complaints

o change controls

o corrective and preventive actions (CAPAs)

• Manages problems of diverse scope using excellent judgement and a high degree of risk-based decision making

• Engages in activities to continuously assess and improve the company’s quality systems, by identifying and proactively resolving quality issues, as needed,

• Reviews and/or approves protocols related to technical services and engineering functions including but not limited to:

o IQ/OQ/PQ

o Process validation

o Cleaning Validation

o Special studies (including Engineering studies and Technical Service studies)

o IT/QA

• Works directly and cross functionally throughout the company (QA/QC managers, Manufacturing and Operations managers, R&D managers, and executive management, etc.) on deviations and product quality complaint investigations relating to production operations, quality operations oversight, and quality control analysis

• Manages, coaches, and mentors direct reports, including: QA Batch Disposition Manager, QA Operations Manager, Quality Documentation Manager, Manager Quality Investigations, and Manager R&D QA.

• Participates and aids in regulatory inspections

Requirements:

QUALIFICATIONS

Bachelor’s degree in a science or related discipline AND minimum 8 years QA and/or Compliance experience in the pharmaceutical or biotechnology industry in positions of increasing technical and strategic responsibility (minimum 5 of those years in a supervisory or manager role). REQUIRED.

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

• Expert knowledge of US FDA cGMPs and working knowledge of global GMP requirements REQUIRED.

• Experience managing quality operations in a pharmaceutical production environment REQUIRED.

• People management experience including experience managing or supervising large groups (20+ employees) REQUIRED.

• Ability to influence without direct authority 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. PM22

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