Associate Director, Clinical Quality Assurance

Summary

Join Apogee Therapeutics as an Associate Director of Clinical Quality Assurance (CQA) and play a key role in establishing a robust QA system for our clinical operations. Reporting to the Head of CQA, you will ensure compliance with regulatory standards and foster a culture of quality. This position requires a Bachelor's degree in a relevant field, 8-10 years of experience in biopharma QA, and at least 6 years of direct GCP audit experience. You will assist in developing and executing audit plans, perform GCP audits, act as a CQA lead in meetings, and provide quality guidance to clinical functions. The ideal candidate possesses strong communication, problem-solving, and teamwork skills, and is comfortable managing multiple projects in a fast-paced environment. Apogee offers a competitive compensation and benefits package, including a great company culture, flexible PTO, and professional development opportunities.

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

Responsibilities

• Assist CQA Leadership with development and execution of CQA audit plans supporting Apogee clinical study programs
• Perform or provide oversight of assigned GCP audits e.g. clinical investigator sites, clinical vendor qualifications, trial master files, internal processes and clinical study documents with minimal supervision
• Act as CQA lead representative at clinical study team meetings and other study related meetings
• Partner with clinical functions to provide quality guidance as required to drive the implementation of fit for purpose procedures that support clinical data and documentation generated activities are executed in compliance with GCP
• Facilitate and/or review the investigation of reported quality events to evaluate the appropriateness of CAPAs proposed to mitigate risk of issue re-occurrence
• Contribute to the development and maintenance of clinical QA procedures and other governance standards as assigned
• Assist in the periodic reporting of key quality metrics to leadership to assist in driving improvements in GCP compliance across the organization
• Assist in the development and/or delivery of GCP training topics and quality standards as directed
• Assist QA Leadership in fostering a culture of quality and continuous improvement within the organization, emphasizing the importance of compliance, data integrity, and patient safety in support of corporate goals
• Collaborate with clinical functions to support inspection readiness activities
• Perform key activities during regulatory authority inspection and/or external audits as directed by Head of CQA

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient 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