VP, Head of Quality

Tris Pharma, Inc. (www.trispharma.com) 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.

Position Summary

The Vice President (VP), Quality and Compliance manages the total compliance function of the organization. This includes, but is not limited to: ensuring adherence to, and compliance with, established company quality policies, practices, standard operating procedures (SOPs) and federal regulations, directing the quality of materials purchased, processed, manufactured and/or distributed by the company, overseeing and ensuring compliance with all appropriate regulatory agencies, etc. The incumbent also contributes to the strategic development and management of Tris’ Quality and Compliance operations. 

The VP, Quality and Compliance is accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Essential Functions:

· ensures compliance with all current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and Occupational Health and Safety Administration (OSHA) regulations, as well as all applicable company compliance guidelines, standards, and objectives 

· Leads and manages inspections by FDA, other regulatory agencies, and company’s commercial partners

· Coordinates with regulatory agencies and other external auditors to build trust and confidence in the site’s quality systems

· Leads quality input on contracts and serve as the primary contact for quality agreement negotiation

· Ensures that quality activities in support of corporate initiatives are adequately staffed and that timelines are met in a quality manner; Establishes and manages quality metrics, including Right First Time (RFT), responsible for ensuring that all policies and procedures associated with the department are created, current and followed

· Ensures training and preparedness of the company at all levels for cGMP compliance

·  Serves as the quality resource/expert for process development, technology transfer, equipment and facility engineering, validation, and troubleshooting

· Works with the company’s external suppliers including Clinical Research Organizations (CROs) and contract labs to ensure consistent quality and compliance

· Develops, manages, and monitors adherence to the overall Quality and Compliance budget

· Develops, analyzes, and reports business metrics and highlights 

· Collaborates closely with the Commercial, Research and Development (R&D), and Regulatory Affairs teams for New Product Launches

· Manages, mentors, coaches, and develops direct and indirect reports to build competencies and assure proper succession planning is available

· Fosters an environment of employee engagement by leading by example and embracing a continuous improvement culture

· Strictly adheres to ethical and good manufacturing practices; develops, implements, and follows high standards of research and corporate conduct

Knowledge/Skills/Abilities Required

Minimum education and years of relevant work experience

Bachelor’s degree in science or related field AND minimum 10 years’ experience in the pharmaceutical or biotechnology industry in quality or compliance related environment in positions of increasing strategic and leadership responsibility (minimum 5 of those years managing direct and indirect reports). 

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

· Excellent, current knowledge of cGMPs in the pharmaceutical industry 

· Excellent understanding and experience working with multiple dosage manufacturing and packaging

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

· Proven record of developing and maintaining successful working relationships with regulatory agencies including, but not limited to: FDA, DEA, and OSHA

· Ability to influence without direct authority 

· Proficiency with Microsoft Office 

· Excellent verbal and written communication skills 

· •Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members 

· Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 

· Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects 

· Fluent in English (verbal and written) 

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

· Advanced degree (MS, MBA )

· Certified Quality Auditor (CQA) or equivalent certification

Travel requirements

Less than 10% 

Physical requirements

Office based position

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.