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CAREER OPENINGS


Associate Director, Quality Assurance

ID: 1610
Department: Quality
Location: Cambridge Headquarters
# of Openings: 1

Description

We are seeking a resourceful leader and collaborative partner to join our Quality Assurance team to build our GCP quality function. In this role you will provide strategic GCP compliance oversight for our clinical studies and internal operations. We are seeking a candidate who can design, plan and execute risk-based audit strategies to ensure patient safety, while fostering a culture of excellence throughout the company. If you thrive on working collaboratively to solve challenges in a fast-paced, dynamic environment, this role will provide you with meaningful leadership opportunities and position you to have significant impact on building our company.  

The candidate we are seeking is a subject matter expert in GCP regulations, clinical trial operations and quality systems, that will ensure our compliance to applicable regulatory standards, industry best-practices and internal procedures, while also identifying and supporting continuous improvement initiatives.  The ideal candidate for this exciting opportunity has held progressive leadership roles in Quality Assurance for a pharmaceutical or biologics company and is able to independently manage a wide-range of GCP quality oversight operations with minimal supervision. To support Quality Assurance’s customers and business partners, both within our team and with our external vendor network, this candidate must operate with a high level of professionalism, use collaborative approaches and possess excellent written and verbal communication skills. In this highly visible leadership role you will drive quality initiatives with senior management and must be able to lead and influence decisions at all levels in the company to ensure successful outcomes of the company’s business objectives.

 

Responsibilities:

  • You will collaboratively design and build the GCP quality operational processes and functional requirements for our company.

  • You will develop risk-based audit plans and strategies and be responsible for the GCP compliance oversight of internal and external operations.

  • You will build strong relationships with cross-functional teams and serve as the GCP subject matter expert on multiple project teams.

  • You will drive risk mitigation, continuous improvement, and issue resolution initiatives to advance our quality systems and internal operations.

  • You will champion GCP quality throughout the company and lead discussions on GCP compliance with senior management. 

 

Required Qualifications:

  • Bachelor’s Degree in Allied Health or a Scientific Discipline.

  • At least 12 years’ experience in the pharmaceutical industry with a GCP focus, with at least 5 years in a GCP quality/compliance role.

  • Subject matter expertise in US GCP regulations and guidance.

  • Experience conducting quality audits of CROs and Investigational Sites.

  • Strong organizational and interpersonal skills, specifically including the ability to build positive relationships with effective communication, influencing, conflict resolution, critical thinking, and problem solving.

 

Preferred Qualifications:

  • Knowledge of global GCP regulations.

  • Experience providing quality oversight for clinical trials conducted in regions outside the United States.

  • Experience establishing GCP operating procedures and business policies.

  • Experience in computer system validation or auditing vendors that provide electronic systems for clinical trials.

  • Experience with vendor oversight and managing relationships with external stakeholders. 


Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.





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