Director, Quality Assurance – Compliance and Batch Disposition
Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.
Role Overview:
Director of Quality Assurance – Compliance and Batch Disposition
We are seeking a highly experienced and motivated Director of Quality Assurance to lead the company’s Quality compliance and batch disposition activities. Reporting to the Executive Director of GMP Quality Assurance, this role is critical in ensuring that all products meet regulatory and company standards for quality, safety, and efficacy. The Director will oversee the QA compliance program, manage the batch disposition process, and maintain a culture of quality and continuous improvement.
Position Responsibilities:
- Compliance Management
- Maintain and improve the existing Quality Management System (QMS) to ensure compliance with FDA, EMA, ICH, and other applicable regulatory requirements.
- Participate in inspections and audits conducted by regulatory agencies, customers, and internal teams; ensure timely and effective responses to observations.
- Review / approve GMP change controls (internal and external) for implementation, ensuring that they capture appropriate action items and are executed and closed in a timely manner.
- Ensure investigation of deviations, non-conformances, and out-of-specification results is thorough, documented, and resolved before batch disposition.
- Collaborate with external Contract Organizations to ensure alignment and reconciliation of comments and edits
- Monitor changes in regulatory requirements and industry standards; update company policies and procedures accordingly.
- Collaborate with the QA Training group to enhance awareness and compliance across all functions.
- Conduct risk assessments to identify compliance gaps and drive mitigation plans.
- Batch Disposition
- Oversee the review and approval of batch records, ensuring compliance with GMPs and product specifications.
- Collaborate with external Contract Organizations to ensure all documentation relevant to batch dispositions are acceptable.
- Ensure that all documentation required for batch disposition is archived in Veeva QualityDocs and linked to the correct batch.
- Serve as the final QA approver for batch disposition, ensuring timely release or rejection of Madrigal’s products.
- Collaborate with cross-functional teams, including Manufacturing, QC, and Supply Chain, to address issues impacting batch release.
- Leadership and Team Development
- Lead and mentor a high-performing QA team with expertise in compliance and batch disposition.
- Provide clear goals, performance feedback, and development opportunities for team members.
- Foster a culture of accountability, continuous improvement, and collaboration across the organization.
- Documentation and Reporting
- Oversee the development, review, and approval of SOPs, policies, and controlled documents related to QA compliance and batch disposition.
- Prepare and present metrics, trends, and reports on quality and compliance to department management.
- Participate in quarterly Quality Management Review meetings
- Participate as needed in Quarterly Business Review meetings with external manufacturing organizations
- Assist in implementing and maintaining Quality Agreements with GxP contractors and vendors
- Continuous Improvement
- Identify and implement process improvements to enhance compliance, efficiency, and product quality.
- Partner with operational teams to proactively address potential quality risks in manufacturing processes.
- Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Science). Advanced degree preferred.
- Minimum 10 years of experience in Quality Assurance, with at least 5 years in a leadership role in a GMP-regulated environment.
- In-depth knowledge of global regulatory requirements, including FDA, EMA, ICH guidelines, and other applicable standards.
- Proven track record in participating in regulatory inspections, managing quality systems, and batch disposition processes.
- Strong analytical and problem-solving skills, with a focus on root cause analysis and risk management.
- Exceptional leadership, communication, and interpersonal skills.
- Excellent writing skills
- Experience with electronic quality management systems (eQMS) such as TrackWise, MasterControl, or Veeva. Experience with Veeva preferred.
- Familiarity with synthetic drug substances and oral solid dosage forms.
This position operates in a fast-paced, highly regulated environment. It requires a hands-on approach, attention to detail, and the ability to manage multiple priorities effectively.
Compensation:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.
Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.