Associate Director, Quality Assurance
Role: Associate Director, Quality Assurance
Company: Profound Research
Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and patients get access to the newest therapies available
Mission, Vision, Values
- Mission: Ensure that every patient has access to innovative treatments and improve patient lives.
- Vision: The future of medical innovation rests in the hands of physicians and their everyday care delivery decisions.
- Compassion: Honor the patient-physician relationship above all else.
- Efficiency: Accountable for outcomes and strive for process perfection.
- Progress: Contribute to continued innovation in medicine while improving health outcomes.
- Integrity: Hold ourselves to the highest ethical, quality, and scientific standards in every activity.
- Physicians are the Vanguard
- All Decisions Improve Patient Care
- Never Compromise Quality
Why this Role Exists
We are seeking a highly skilled and motivated Quality Assurance professional to join our team. If you are passionate about implementing quality processes and collaborating with clinical research teams to ensure quality, patient safety, and data integrity, we want to hear from you.
As the Associate Director of Quality Assurance, you will play a pivotal role in maintaining and enhancing Profound’s quality management system in accordance with regulatory requirements and industry standards. This position is responsible for overseeing quality documentation management processes and ensuring they remain in line with the highest standards of clinical trial quality. The successful candidate will implement and manage the electronic Quality Management System (QMS), ensure appropriate policies and procedures are in place across the organization, develop and monitor quality assurance-related metrics, and lead efforts to continuously improve quality assurance practices.
Key responsibilities include:
- Quality Management System (QMS) Oversight: Develop and maintain a comprehensive quality management system for clinical research, ensuring alignment of policies and procedures with organizational goals, GCPs, and regulatory requirements. Includes implementation and management of the electronic QMS platform.
- Quality Events and CAPA: Responsible for quality event and CAPA management processes, including mechanisms to track timelines and completion of tasks.
- Audit Hosting and Management: Coordinate and host customer audits and regulatory authority inspections. Develop and implement strategies for pre-audit preparation and post-audit follow-up actions, including supporting responses and corrective actions as needed.
- Metrics: Develop and monitor a comprehensive set of quality-related metrics aligned with industry standards and organizational goals.
- Risk Management: Develop a risk management process and related tool(s). Leverage developed process to lead risk management activities, identifying potential areas of risk and developing strategies to mitigate such risks.
- Continuous Improvement: Lead efforts to continuously improve clinical trial quality by implementing best practices and innovative solutions.
- Regulatory Awareness: Stay abreast of regulatory changes as they relate to clinical trial research and implement necessary modifications to internal processes.
- Quality Culture: Mentor and guide Profound team members, fostering a culture of quality and compliance.
Note: This job description is intended to provide a general overview of the position and should not be considered an exhaustive list of responsibilities and qualifications. Responsibilities and qualifications may vary depending on the specific role and project requirements.
- Bachelor's degree in a relevant scientific, quality, regulatory, or business administration field.
- Minimum of 8 years’ experience in the pharmaceutical industry and/or GXP environment (ex: GCP, GLP).
- Proven experience in implementing and managing electronic quality management systems.
- Strong knowledge of Good Clinical Practices and clinical trial regulations and guidance (ex: 21 CFR Parts 50, 54, 56, 312; ICH E6).
- Ability to collaborate effectively with cross functional teams and appropriately communicate and resolve potential issues.
- Experience hosting and preparing internal teams for Customer audits and/or regulatory inspections.
- Detail-oriented with a strong commitment to quality and compliance.
- Excellent communication, leadership, and problem-solving skills.
- Experience supporting clinical trial sites and/or site networks.
- Skilled in leading root causes analysis (RCA) discussions and assisting study teams in identifying appropriate corrective and preventive actions.
- Ability to travel up to 20%.
- Prolonged periods of sitting at a desk and working on a computer, standing and walking.
- Must be able to lift 25 pounds at times.
- Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.
- Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.
- Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound.
- The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.