Description:
We are seeking a dynamic and results-driven Associate Director of Clinical Quality Assurance (CQA)
This key role will report to the Head of Clinical Quality Assurance
Responsible for assisting with the establishment of a robust QA system for our clinical operations
Ensure compliance with regulatory standards, and promote a culture of quality throughout the organization
Requirements:
Bachelor’s degree in a relevant biological sciences or equivalent is required, advanced degree a plus
8-10 years professional experience in Quality Assurance within the biopharma industry, including increasing responsibilities in the Clinical QA function
Minimum of 6 years of direct audit experience in GCP
In-depth working knowledge of GCP regulations and guidelines, including FDA, EMA, and ICH requirements
Extensive experience using electronic QMS to monitor, report, and track quality tasks and key quality performance indicators
Strong communication (oral and written), effective interpersonal skills with the ability to listen and drive change
Excellent problem-solving and critical thinking abilities
Flexible and creative to meet the needs and challenges of a growing, dynamic company
Focus on fostering a culture of collaboration and teamwork
Ability to manage multiple projects with aggressive timelines and changing priorities
Ability and willingness to travel up to 25% per year including for company meetings
Benefits:
A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Flexible PTO
Two, one-week company-wide shutdowns each year
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve
