Manager, Quality Management (Carlsbad/Oceanside, CA)
Role: Manager, Quality Management
Company: Profound Research
Location: Hybrid – Carlsbad, CA or Oceanside, CA and Detroit, MI
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 your patients get access to the newest therapies available while you open up a new ancillary for your practice.
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 skilled and motivated Quality Management professional to join our team. If you are passionate about conducting quality processes and collaborating with clinical research teams to ensure quality, patient safety, and data integrity, we want to hear from you.
As Manager, Quality Management, you will play a pivotal role in ensuring the execution of clinical trials in accordance with regulatory requirements, industry standards, and company policies by completing quality management reviews. The successful candidate will collaborate with cross-functional teams, conduct clinical trial data reviews, provide regulatory guidance to clinical trial personnel, support customer audits and FDA inspections, and support efforts to continuously improve quality management practices.
Key responsibilities include:
- Compliance Oversight: Collaborate with clinical study teams to ensure clinical trials comply with relevant regulatory requirements, Good Clinical Practices (GCP), protocols, and company policies.
- Quality Reviews: Conduct quality-focused reviews of clinical trial data and records, assessing compliance to the protocol, GCP, good documentation practices (GDP/ALCOA), and company policies.
- Audit and Inspection Support: Prepare study teams for study/site-specific customer audits and regulatory inspections, including supporting responses and corrective actions as needed.
- Training and Education: Support delivery of training programs for clinical trial personnel regarding quality management processes, GCP, GDP/ALCOA, and other relevant topics.
- Issue Resolution: Collaborate with study team members to investigate and resolve quality-related issues and to complete root cause analysis (RCA) and corrective and preventive actions (CAPAs) as necessary.
- Continuous Improvement: Support efforts to continuously improve clinical trial quality by employing best practices and bringing innovative solutions.
- Quality Culture: Provide quality guidance to study teams. Foster a culture of quality and accountability, to ensure protection of participant safety and data integrity.
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 or healthcare field.
- Minimum of 2 years’ experience in clinical quality within the pharmaceutical industry.
- Strong knowledge of Good Clinical Practices and clinical trial regulations and guidance (ex: 21 CFR Parts 50, 54, 56, 312; ICH E6).
- Proficient at reviewing clinical trial data and regulatory (essential documents) in both paper and electronic formats (e., electronic source and electronic regulatory systems).
- Ability to collaborate effectively with cross functional teams and appropriately communicate potential issues.
- Experience preparing study teams for and supporting customer audits and/or regulatory inspections.
- Experience in leading root causes analysis (RCA) discussions and assisting study teams to identify appropriate corrective and preventive actions.
- Detail-oriented with a strong commitment to quality and compliance.
- Strong analytical skills and problem-solving abilities.
- Ability to be onsite at a Profound clinical trial site approximately 2-3 days per week as needed.
- Experience supporting clinical trial sites and/or site networks.
- Experience using an electronic Quality Management System (QMS), CRIO, and/or Complion.
- Experience in roles such as clinical research coordinator.
- Experience delivering GCP-related training to clinical study teams.
- Ability to travel up to 15%.
- 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.