Associate Director, Quality (GCP/GLP)

 

About Aquinox:

Aquinox Pharmaceuticals, Inc. is a late clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology. Our primary focus is anti-inflammatory product candidates targeting SH2-containing inositol-5'-phosphatase 1, or SHIP1, which is a key regulator of an important cellular signaling pathway in immune cells, known as the PI3K pathway. Our lead product candidate, rosiptor (AQX-1125), is a small molecule activator of SHIP1 suitable for oral, once daily dosing. Having successfully completed multiple preclinical studies and seven clinical trials with rosiptor (AQX-1125), we are now in a Phase 3 program with our lead indication of interstitial cystitis/bladder pain syndrome (IC/BPS). Other indications are under consideration for future investigation. Aquinox has a broad intellectual property portfolio and pipeline of preclinical drug candidates that activate SHIP1. 

We are a focused team, achieving our goals through our values based culture. Our people are highly results-oriented, proactive and collaborative. 

Aquinox is publicly traded on NASDAQ (AQXP) with offices in Vancouver, BC, Canada and in San Bruno, CA, USA.

The Opportunity:

Reporting to the Senior Director, Quality and located in either our San Bruno or Vancouver offices, the Associate Director serves as a leader in establishing direction of activities related to development and direction of the Global Clinical Quality strategy, objectives, policies and programs pertaining to development and marketing of drug products for Aquinox and its subsidiaries.

Specifically, Associate Director will:

  • Reporting to the Senior Director of Quality, serves as the lead on GCP compliance matters for the Company.
  • Collaborates cross functionally to identify and implement GCP policy and procedures in compliance with GCP regulations/guidelines for managing Aquinox clinical study programs.
  • Provides Quality review and input to a variety of document types generated directly by internal Clinical staff and external CROs and other contract service providers.
  • Acts as alternate in the absence of the Senior Director, Quality, on senior cross functional project teams.
  • Partner with CROs and other contract service providers to assure risk-based GCP quality systems processes and procedures are deployed to the fullest extent possible.
  • Assures clinical trials are conducted in accordance with study protocol requirements and in compliance with GCP and ICH guidelines and local requirements.
  • Assures contracts with CROs and other clinical service providers activities are in compliance with applicable standards and regulatory requirements.
  • Develops audit plans and conducts GCP compliance audits of investigator sites, CRO facilities, depots, and other clinical service providers for study-specific compliance as appropriate.
  • Creates key quality metrics for tracking and trending data related to GCP activities, report metrics, and significant quality incidents to QA management.
  • Conducts and coordinates GCP compliance training to internal and external customers as appropriate.
  • Supports inspection readiness preparations (internal and external) and interactions with regulatory agencies during inspections on GCP related matters.
  • Supports the continuous improvement and management of Aquinox Quality Systems.

 What you bring:

  • Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
  • Proven ability to work with a high level of integrity, accuracy, and attention to detail.
  • Proven ability to manage multiple projects, identify and resolve Quality issues.
  • Strong technical/analytical skills to identify and solve problems.
  • Excellent oral and written communication skills for effectively interfacing with all levels  of management, departments within the company and with external contract service providers.
  • Ability to make thoughtful, integrated, timely and meaningful decisions from diverse perspective inputs and take corresponding actions, including escalation.
  • Proactively seeks out and recommends process and systems improvements within the company and externally with contract service providers.
  • Ability to influence the development cross-functional team in a positive way.
  • Ability to function well with volatility, uncertainty, complexity and ambiguity.
  • Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.
  • Ability to balance Quality objectives with business objectives, maintaining safety of clinical subjects and integrity of clinical study at all times.
  • Entrepreneurial, enjoys working in a fast-paced, small-company environment.

 Job Requirements

  • Minimum B.Sc. in a scientific discipline required.
  • Must have 10 years of experience in GCP environment with at least 5+ years of experience in a Quality leadership role, preferably in late stage clinical research.
  • Must have relevant auditing experience, both internal and external in the GCP environment.
  • Experience in implementing and maintaining quality systems in a GXP environment.
  • Experience with FDA and other health authority inspections.
  • Extensive knowledge of US and EU GCP compliance regulations and industry practices, as well a working knowledge of ROW regulations
  • This position will require a significant amount of travel (up to 35%) domestic and international.

Our current clinical trials, exceptional team, and strong track record make it an excellent time to seize this exciting opportunity! We provide a collaborative and innovative environment with competitive incentive packages and rewards. Moreover, we provide the opportunity to partake in meaningful work.

Interested candidates are invited to forward their resume and cover letter to careers@aqxpharma.com, indicating why you feel you are a fit for the Associate Director, Quality role at Aquinox Pharmaceuticals, Inc.

We thank all applicants for their interest; however, due to the volume of resumes we receive, only those chosen for an interview will be contacted.