Sr. Director, Quality Operations

Kindeva Drug Delivery•Bridgeton, MO

3d•Onsite

About The Position

Sr. Director of Quality Operations is responsible for leading all Quality Assurance (QA) functions at the St. Louis GMP manufacturing focused in sterile fill-finish drug products and combination products. This commercial facility operates as a Contract Manufacturing Organization (CMO), providing services to global clients. The role ensures full compliance with regulatory requirements while fostering a culture of quality, operational excellence, and inspection readiness.

Requirements

Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field (advanced degree preferred).
15+ years of progressive GMP Quality experience, including at least 8 years in sterile drug product manufacturing.
Combination product experience required.
Demonstrated success in leading Quality organizations and hosting regulatory inspections.
Expert knowledge of cGMPs, Annex 1, ISO 13485, ICH guidelines, and combination product regulations.
Strong leadership, influencing, and organizational skills.
Proven ability to implement process improvements and lead through change.
Excellent problem-solving and decision-making capabilities.
High ethical standards and professional integrity
Position requires vision acuity testing and onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis.
The candidate must be able to complete aseptic gowning qualification and work in a Grade A/B classified area.
It is required to sit, stand and occasionally lift items (up to ~25 pounds), performing the duties of this position.
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications, and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.

Nice To Haves

advanced degree preferred

Responsibilities

Provide overall leadership for the site Quality operations organization
Act as a key member of the site leadership team, ensuring alignment of quality with manufacturing, engineering, supply chain, and regulatory functions.
Drive a culture of compliance, data integrity, and continuous improvement across the site.
Represent the site in global quality governance to ensure harmonization of systems and processes.
Ensure timely batch release decisions in alignment with cGMPs, regulatory standards, and client expectations.
Direct preparation for and management of regulatory inspections and client audits.
Provide oversight of deviations, CAPAs, change controls, and risk management.
Ensure compliance with combination product quality requirements (drug-device interface).
Ensure site operations comply with FDA, EMA, ICH, ISO 13485, and other global requirements.
Serve as the primary contact for regulatory inspections and audits.
Stay ahead of evolving regulations and implement proactive compliance strategies.
Lead, develop, and mentor QA teams to build a high-performing organization.
Establish clear roles, career pathways, and succession planning for Quality leadership.
Promote collaboration, open communication, and accountability across all functions.