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Manager/Director, Clinical QA

Trevena is seeking a Manager/Director, Clinical QA to support the GXP compliance and Quality Unit function at Trevena.  Primary responsibilities will include ensuring the compliance of clinical operations with cGCPs, though the Manager/Director, Clinical QA also is likely to provide support with GLPs, GMPs, and QA systems.  The Manager/Director, Clinical QA will have a critical role in ensuring NDA inspection readiness.

Basic qualifications:

  • Bachelor's Degree or above in Life Sciences or related field. 
  • Minimum of 7 years of experience working in GXP environments in the pharmaceutical/ biotechnology industry.
  • Minimum of 3 years of experience working a quality assurance (GCP, GLP or GMP)  or directly related role.
  • Experience with clinical trial logistics, including investigations and risk assessment for on-going activities and assessing capabilities of potential and clinical and non-clinical development programs from a quality and compliance perspective
  • Prior experience in dealing with FDA and other regulatory agency personnel and understanding of their requirements/expectations.
  • Knowledgeable and experienced in implementing US and ICH cGMP, GCP, and GLP regulations and guidelines. Demonstrated ability to ensure compliance with the above regulations and guidelines.
  • Excellent interpersonal, verbal, and written communication skills.
  • Ability to work professionally with highly confidential information.
  • Willingness to work with multiple disciplines on multiple projects in a fast-moving environment, and to value the importance of teamwork. 
  • Strong judgement and decision-making skills with the ability to understand how decisions fit into corporate strategies.

Preferred qualifications:

  • Advanced degree in a scientific discipline.
  • Hands- on experience in clinical operations preferred.
  • Preference will be given to candidates with experience working in small company and virtual company environments.
  • Knowledge of non-clinical development process is preferred.

Submit your resume for consideration for this role to qa-applicant@trevenainc.com

Trevena’s Culture

We believe in our science and in the people that make it possible. As a small company, every employee is critical to our success and we strive to make sure that every voice is heard. We all sit in an open-plan office with no physical barriers to communication and interaction across disciplines and across levels. The company’s goals, challenges and successes are clearly outlined and we work as one team to make the organization successful.

We empower our employees to make their contribution count. Every employee has an opportunity to impact Trevena’s success and to benefit personally from that success as a shareholder of the company.

We work hard but we also have fun. Whether it’s sharing a home-made cake in the break room, running off calories together in Valley Forge park or throwing gutter-balls at Trevena bowling night, there is a strong focus on social as well as scientific interaction.

At Trevena, we have built a great team, who are committed to ground breaking science, and to each other. We involve all key team members in hiring decisions and are delighted that the culture of passion, commitment and fun stays strong as the company continues to grow.

Trevena’s Location – King of Prussia, PA

The Trevena site is a custom-built office and laboratory space in King of Prussia, Business Center. The Business Center provides access to a café, a small gym and shower facilities. For the outdoor enthusiast, Valley Forge park is on the doorstep and for shopping/dining, King of Prussia Mall is close by.

In the broader area, there are a multitude of attractive, communities where our employees can base themselves. From the Philadelphia Main Line through to West Chester, towns include Bryn Mawr, Radnor, Villanova, Wayne, Devon, Berwyn, Paoli and Malvern. Even closer to the site, employees live in King of Prussia, Conshohocken, Phoenixville and Audubon. There are many opportunities to base yourself near great schools, restaurants, farmers’ markets etc.

The Trevena region is part of the Greater Philadelphia’s Life Sciences Cluster, an active, vibrant and supportive community working to accelerate the growth of life sciences companies. This region achieved top rankings in the 2009 Milken Report due to a strong blend of established pharma, research infrastructure, world-renowned universities, emerging startups, workforce, and support network for entrepreneurs.

Source: Select Greater Philadelphia

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