Director of Referral Services overseeing the referral processes at BioMatrix. Focused on patient referrals, prescription activities, and team management in specialty pharmacy.
About the role
- Senior Director, Quality providing leadership for the Quality Management System at Meitheal Pharmaceuticals. Overseeing compliance and operational initiatives for generics, biologics, and devices.
Responsibilities
- Provide strategic and operational leadership for Meitheal Pharmaceuticals’ Quality Management System (QMS) across generics, biologics, biosimilars, and device programs.
- Oversee quality operations, partner quality oversight, inspection readiness, and continuous improvement initiatives to ensure compliance with regulatory requirements.
- Work cross-functionally with Regulatory Affairs, Operations, Pharmacovigilance, and Commercial teams to drive inspection readiness, product launch quality, and global partner alignment.
- Lead the continued development and implementation of a fit-for-purpose QMS that supports generics, biologics, biosimilars, and devices.
- Ensure all QMS elements (change control, deviation, CAPA, training, document control, complaint handling, and batch disposition) are implemented, compliant, and continuously improved.
- Drive QMS remediation and sustainment activities based on internal audits and gap assessments.
- Lead the development and execution of Meitheal’s inspection readiness strategy, ensuring continuous compliance with FDA, ICH, and international standards.
- Oversee preparation and coordination of regulatory inspections, mock audits, and partner audits.
- Serve as a key contact for regulatory agencies during inspections and audits.
- Provide oversight of all contract manufacturing organizations (CMOs), testing laboratories, and suppliers to ensure compliance with cGMP and Quality Agreements.
- Establish and maintain governance structures, KPIs, and performance monitoring for key partners (NKF, Kindos, and other affiliates).
- Lead resolution of quality issues, CAPAs, and audit findings in collaboration with partners.
- Support change control, complaint handling, and annual product quality reviews (APQRs).
- Support product launch readiness, ensuring quality documentation, packaging validation, and stability data are in place.
- Provide quality leadership for lifecycle management and post-market quality programs.
- Support digital QMS initiatives including TrackWise Digital, ValGenesis, and other validated systems.
- Drive data integrity, audit trail management, and computerized system compliance per 21 CFR Part 11 and Annex 11.
- Collaborate with IT and business functions to enhance data governance and analytics.
- Lead, mentor, and develop the Quality Systems and Compliance teams to build technical expertise, accountability, and engagement.
- Foster a proactive, solution-oriented, and collaborative Quality culture across the organization.
- Represent Quality in cross-functional governance committees and decision-making forums.
Requirements
- Minimum of a bachelor’s degree in a scientific discipline; advanced degree preferred.
- Minimum 15 years in pharmaceutical or biotechnology Quality Assurance.
- Minimum 7 years in a leadership role with demonstrated success managing quality systems and partner oversight.
- Experience with biologics/biosimilars and combination products strongly preferred.
- Prior experience with virtual or outsourced manufacturing models (CMOs, CTLs, 3PLs).
- Proven record of success during FDA inspections.
- Strong knowledge of 21 CFR Parts 210, 211, 600–680, 820, and ICH Q7–Q12.
- Understanding of data integrity, Annex 11, and GAMP 5 principles.
- Hands-on experience with TrackWise Digital, or similar systems.
Benefits
- Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.
- Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.
- Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.
- Professional Growth: We offer ample opportunities for professional development and career advancement.
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