Join us as our Director, Quality Assurance

Thryv Therapeutics Inc. (previously LQT Therapeutics Inc.) is a privately owned company based in Montreal, Quebec, Canada.  Thryv Therapeutics is pioneering a precision medicine approach to treat genetic and drug-induced Long QT Syndromes, atrial fibrillation and resistant cancers with potent and selective inhibitors of Serum Glucocorticoid inducible Kinase.

OPPORTUNITY SUMMARY

The Director, Quality Assurance will be responsible for the GMP audit and compliance functions of the Quality Assurance Department, including QA documentation, and support for GLP and GCP operations.  This position will report directly to the President.

 RESPONSIBILITIES

  • Directs the development, implementation, and execution of Quality Assurance systems and activities to ensure reliability, quality, efficacy and compliance with all applicable state, federal, and international (where appropriate) regulations.

  • Responsible for GMP compliance in the review and approval of manufacturing batch records and testing/release records in support of development, clinical and/or manufacturing cGMP operations.

  • Directs and provides guidance in writing and reviewing SOPs.

  • Provides managerial guidance Document Control, Validation and Training.

  • Responsible for all audit functions.  Ensures that periodic internal and external audit plans are maintained, conducted, reported, and responded to in a timely manner.

  • Insures documentation suitability against regulatory standards and approves IND and BLA submissions confirming compliance of approved practices and procedures.

  • Directs all training to support cGXP activities.

  • Presents information/reports to senior level management regarding the status of the company related to cGXP standards.

EDUCATION & WORK EXPERIENCE

  • BS in chemistry or related scientific field

  • 10+ years’ experience in the pharmaceutical industry, with majority of experience in Quality Assurance

TECHNICAL KNOWLEDGE & SKILLS

  • Detailed knowledge of current Good Manufacturing Practices (cGMPs)

  • Extensive experience in compliance auditing for cGXPs

  • Experience in training and implementing procedures compliant with FDA regulations

  • Experience with Quality documentation systems and controls

NON-TECHNICAL SKILLS AND COMPETENCIES

  • Exudes the highest level of integrity and an acute sense of ethics

  • Operates with a sense of urgency and perseverance to achieve results

  • Superior problem solving, conflict management and interpersonal skills

  • Ability and enthusiasm to work in a cross-functional team environment

  • Superior organizational skills and the ability to multi-task and prioritize competing assignments

  • Excellent oral/written communication, interpersonal, organizational and presentation skills

  • Proactive and self-motivated with the ability to work independently with minimal supervision

  • Ability to work under pressure to meet deadlines

  • Strong leadership qualities

EQUAL OPPORTUNITY WORKPLACE

Thryv Therapeutics is proud to be an equal opportunity employer. We are committed to equal employment opportunity regardless of race, colour, religion, sex, sexual orientation, gender identity, age, national origin, disability and any other characteristic protected by law.

APPLY

Please send your resume and cover letter to admin@thryvtrx.com