Sr. Director / Site Head of Quality

Kindeva Drug Delivery•Los Angeles, CA

1d•Onsite

About The Position

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The Sr Director / Site Head of Quality is responsible for leading all Quality Assurance (QA) and Quality Control (QC) functions at the Northridge facility operating as a Contract Manufacturing Organization (CMO) focused on large scale commercial GMP manufacturing of transdermal and inhalation combination drug products. This role ensures full compliance with regulatory requirements while fostering a culture of quality, operational excellence, and inspection readiness. This role requires significant on-site presence

Requirements

Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field (advanced degree preferred).
15+ years of progressive GMP Quality experience
Demonstrated success in leading Quality organizations and hosting regulatory inspections.
Extensive experience in a contract manufacturing environment, demonstrated ability to manage quality responsibilities across multiple simultaneous client programs with varying regulatory requirements and quality agreements.
Extensive combination product experience with demonstrated working knowledge of the drug-device interface quality framework under 21 CFR Part 4, 21 CFR Part 820, and ISO 13485, including primary mode of action determinations and device constituent part controls applicable to transdermal and inhalation delivery systems.
Significant experience in commercial manufacturing of combination drug products, including familiarity with associated QC testing requirements (e.g., APSD, device performance, extractables and leachables).
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.
Demonstrated mentoring and talent development skills, proven track record of building and growing quality professionals through coaching, structured development plans, and investment in technical and leadership capability at all levels of the organization.
Strong operational focus with the ability to translate regulatory requirements into practical, scalable quality processes that support commercial manufacturing efficiency; skilled at identifying and removing quality-related barriers to operational performance.

Responsibilities

Provide overall leadership for the site Quality organization, spanning QA and QC.
Act as a key member of the site leadership team, ensuring alignment of quality with manufacturing, engineering, and supply chain 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.
Champion a strong operational focus across the quality function, ensuring quality activities are structured to support commercial manufacturing throughput, schedule adherence, and CDMO client commitments without compromising compliance.
Manage quality resources and priorities across a multiproduct site, balancing simultaneous commercial programs for multiple CDMO clients with varying quality agreements and regulatory requirements.
Oversee site Quality Management System (QMS) implementation and continuous improvement.
Ensure timely batch release decisions in alignment with cGMPs, regulatory standards, and client expectations.
Provide oversight of deviations, CAPAs, complaints, change controls, and risk management.
Ensure compliance with combination product quality requirements (drug-device interface).
Lead all QC laboratory operations, including microbiology, chemistry, and device testing.
Ensure qualification, calibration, and validation of methods and instruments.
Maintain robust sterility assurance and contamination control programs in line with Annex 1.
Oversee method transfers, validations, and client collaborations for analytical support.
Manage QC throughput and turnaround performance to support commercial release timelines across multiple concurrent client programs, with clear metrics and escalation processes in place.
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.
Monitor and interpret evolving combination product regulations and lead timely implementation of any changes affecting transdermal and inhalation product programs at the site.
Maintain a state of continuous inspection readiness across all site quality systems.
Lead, develop, and mentor QA and QC 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.
Actively mentor quality professionals at all levels, investing in the individual growth of direct reports and developing the next generation of quality leaders with deep combination product and CDMO expertise.