Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.

Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.

Understanding the evolving regulatory landscape to build and enhance fit for purpose quality structure that enable Good Clinical Practice (GCP) excellence. The Clinical Quality team strives to ensure that the clinical quality management system (QMS) is optimized to foster a culture where quality innovation matches the company’s goals. Implement and optimize the risk-based quality strategy in coordination with the functional areas and Quality team employing a solution-oriented approach to quality management, quality partnership, quality improvement, and quality excellence. 

 

Key Responsibilities

As Clinical Quality Director/Associate Director, GCP you will:  

  • Provide global GCP guidance for cross-functional development teams in order to build robust internal processes that ensure GCP compliant Sponsor oversight of the conduct of clinical trials.
  • Partner with functional departments (e.g., Biometrics, Clinical Operations, and Clinical Development) to enhance a culture of quality. 
  • Participate and lead GCP inspections by regulatory authorities. Manage proactive GCP inspection readiness activities globally.
  • Support questions from regulators, review boards, ethics committees, development partners, etc. 
  • Support and/or lead issue management and corrective/preventive action management activities within company and with external service providers. 
  • Develop and implement risk-based audit plans which may include but are not limited to clinical study sponsor audits, internal audits, clinical investigator audits, system audits, and vendor audits.
  • Conduct and/or oversee audits in accordance with audits plans. 
  • Support efforts to identify and implement new technologies to optimize quality.
  • Instill a culture for cross-functional review, ownership, management and filing of all documentation (internal and external) within the eTMF that is supportive of a clinical trial.
  • Plan and execute vendor management responsibilities.
  • Manage external auditing partners and consultants that may include conducting audits to ensure compliance with contractual agreements .

Your Profile :

  • The ideal candidate will have experience conducting and managing GCP audits and directly supporting Clinical Study Teams.   
  • 10 years of GCP Quality Experience
  • Strong understanding of GCP (e.g., ICH GCP E6 R2; 21 CFR parts 11, 50, 54, 56, 312, 314; European Union Clinical Trials Directive). 
  • Understanding of global clinical and safety regulations.  As well as the clinical development lifecycle.
  • Experience managing and executing GCP audit s.
  • Ophthalmology experience is a plus.
  • Ability to effectively escalate quality concerns to Clinical Quality leadership 
  • Ability to manage multiple simultaneous projects. 
  • Excellent communication and writing skills.
  • Commitment to diversity, equity, and inclusion. 
  • Able to travel ~40% of the time.                    

Working Conditions: Remote or Office based

Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/.

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