Associate Director overseeing IT Infrastructure and End User Services at Kimberly - Clark, ensuring global service standards and operational effectiveness. Collaborating across teams to enhance employee experience through service innovations.
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.
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Assistant Director for Chapter & Council Services at WVU supporting student organizations and initiatives. Providing leadership, guidance, and engagement strategies to foster student learning and values - based experiences.
Director of Federal Government Relations navigating federal legislative strategy for EQT. Representing the company and aligning advocacy efforts in Washington, D.C.
Lead Product and Agile Delivery for a travel insurance provider. Manage teams to optimize product delivery and operations.
OCS Project Director leading executive oversight in rail electrification projects. Ensuring projects are delivered on time and within budget while managing project teams and client relationships.
Art Director developing complex communication layouts and collaborating with creative teams for project success. Involved in refining designs based on team feedback and meeting project deadlines.
Lead global sustainability agenda at Coloplast, ensuring sustainable practices across operations and product supply. Drive integration of sustainability into business strategies and collaboration across teams.
Director of Transport leading transport technology capability with a focus on rail at Baringa. Involves building relationships and integrating emerging technologies for mobility transformation.
Managing clinical supplies logistics and drug product distribution for biopharmaceutical trials at Braveheart Bio. Collaborate with cross - functional teams to ensure timely supply and compliance.
Associate Director acquiring financial interim assignments at Steens & Partners. Building a network while monitoring interim professionals' performance in a collaborative environment.