Position Summary This position will be responsible for GCP/Clinical Quality Assurance activities. The primary responsibilities will be to ensure quality and compliance of Madrigal-sponsored clinical trials with applicable GCP regulations, ICH GCP guidelines, Madrigal SOPs, and current industry standards and best practices. This position reports into the Senior Director, GCP Quality
Key ResponsibilitiesStrategy, Compliance and Oversight - May develop, implement, and/or maintain clinical quality systems and processes to ensure compliance with ICH GCP, FDA, EMA, and other global regulatory requirements
- Ensure R&D clinical trial activities are compliant with ICH and applicable country regulations and guidelines and industry standards and best practices
- Align organization to ICH in implementing a quality culture from the outset of clinical trials to promote patient safety and data integrity
- Apply a risk-based approach by working collaboratively cross-functionally to ensure compliance
- Attend routine internal and external clinical study team and ad hoc calls in support of ongoing quality oversight
- Inform and escalate to management in real-time and/or during routine updates, as appropriate
Vendor and External Partner Quality Management - Engage partnership with external clinical trial vendors via adherence to Quality Agreements and routine meetings; may review Quality Agreements
- Onboard, coordinate and/or manage services provided by external quality auditing partners (planning to closeout)
- Assure through Qualification audits and oversight activities that clinical trial vendors are operating in compliance with all applicable procedures, study documents, regulations/guidelines
- Review CDAs, MSAs or contract/Work Orders
- Conduct or manage internal/external audits (clinical trial vendor, site, TMF, document, internal process) and prepare or review audit reports
Quality Events, CAPAs, and eQMS Management - Lead reviews, manage documentation, track and/or follow-up on Observations/Findings, CAPAs, Quality Event investigations, deviations, etc. through to closure
- May lead quality investigations (QEs), including potential Serious Breach, Fraud/Misconduct, etc.
- Support use of the eQMS via data entry/document upload of quality activities (audits, Findings/Observations and responses, inspections, CAPAs, SOP Deviations and updates, QEs/Investigations)
- Perform/manage SOP reviews or updates, contribute to the annual audit plan and provide input (including metrics) to prepare for Quality Management Reviews
Clinical Documentation and Process Improvement - Review key clinical program or study documents, such as IBs, Protocols/Amendments, Consents, TMF Plans
- May coordinate or manage inspection readiness activities across R&D functions; provide support during global agency inspections
- Conduct or lead other tasks in support of GCP/Clinical Quality activities, including departmental process improvements
- Stay abreast of applicable global regulations, guidance's, and industry best practices
- May manage studies across compounds/therapeutic area programs
- Provide mentorship to other team members, as applicable
Preferred Qualifications- Minimum 7 years of experience in clinical quality assurance within the biopharmaceutical or CRO industry, to include auditing of clinical trial vendors, sites and/or TMFs or internal R&D process audits
- Minimum 3-5 years of experience in a clinical operations role at a CRO or Sponsor, to include management of a study at a cross-functional level
- Experience in inspection preparation and/or supporting health authority/regulatory agency inspections a plus
- Overall qualification by experience to support the responsibilities not limited to those outlined above
- Demonstrated GCP knowledge; GVP/GLP knowledge or certifications a plus
- BS in a scientific or other relevant discipline with equivalent work experience
Key Competencies - Solid understanding of the cross-functional drug development process, including experience interacting with Operations, Data Management, Pharmacovigilance/Safety, Medical, Statistics/Programming, etc.
- Skilled in developing collaborative internal and external relationships, ideally within a global organization
- Business and Operational acumen to include escalation to management
- Ability to interact with all levels within a global organization
- Experience in using eQMS systems, such as Veeva
Madrigal offers a competitive Total Rewards strategy to attract and retain top talent and is inclusive of base pay, bonus, equity, and a generous benefits package. Full-time employees are eligible for base salary, bonus, equity, and a comprehensive benefits suite.
Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs, and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $147,000 - $180,000 per year. We comply with all applicable minimum wage laws.
All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.
