Senior Director, Corporate Quality

Stoke Therapeutics•Bedford, MA

2d•$254,000 - $290,000•Hybrid

About The Position

The Senior Director, Corporate Quality is responsible for ensuring the effectiveness and continuous improvement of Stoke’s Quality Management System (QMS) throughout the product lifecycle from clinical development to commercialization incompliance with global regulations and guidelines. This person will be responsible for providing strategic and operational leadership for the quality systems function at Stoke, expanding Stoke’s QMS and leading Quality Governance. This person is expected to influence Stoke’s quality culture to help reach a sustained state of inspection readiness for all GxP (GMP, GCP, GLP, GVP) activities. This person will also oversee Stoke’s GxP vendor management and audit programs and manage any regulatory inspections at Stoke. This role will report to the Vice President of Quality and will interface closely with other cross-functional groups such as CMC, Clinical Development, Clinical Development Operations, Program Management, Regulatory, Commercial, IT and other functions within Quality.

Requirements

BS/BA, MS in life sciences (i.e., Chemistry, Biology, Engineering disciplines) with 15+ years progressive experience in Biotech or Pharma setting with experience in either developing, implementing and/or managing GxP Quality Systems.
Strong working knowledge of global GxP regulations (FDA, EU, ICH) and guidelines necessary for phase appropriate decision making and representation to regulatory agencies.
Proficient in interpreting GxP regulations toward implementing quality systems for GxP applications in a practical manner.
Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management.
Experience developing strategy and guiding teams to translate strategy into action
Proven ability to build scalable, fit for purpose GxP processes in a lean environment
Experience dealing with FDA and other major regulatory agencies and leading or participating in hosting regulatory inspections.
Possess excellent analytical skills and the ability to communicate complex issues clearly to a broad group of people.
Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based pragmatic decisions in a timely manner.
Hands-on experience managing small teams, and in providing coaching, development and mentoring to employees.

Responsibilities

Aligned with CMC and Clinical Development, establish and lead Stoke’s global compliance strategy for all stages of product development and clinical trial management.
Act as a compliance expert and thought partner to senior leadership.
Accountable for the end-to-end oversight of Stoke’s QMS that spans the entire product lifecycle and its application to all disciplines of GxP.
Oversee the development, implementation, and ongoing effectiveness of Stoke’s QMS in alignment with regulatory expectations across all enterprise functions.
Responsible for establishing the processes and communication mechanisms for regulatory intelligence to assess emerging global regulatory expectations for impact on the organization and Stoke’s QMS to ensure ongoing compliance.
Establish Quality Governance at an enterprise level by setting meaningful quality metrics and KPIs to monitor performance and sustain improvement.
Oversee SOP governance, document control, training management, change management, risk management, data integrity, and GxP computer systems validation.
Represent quality on project teams, as needed and provide GxP compliance interpretation, consultation to maintain and improve compliance to ensure product quality, data integrity and patient safety.
Oversee Stoke’s Internal and External Audit Program to coordinate required audits, monitor for signals and trends and ensure the implementation of appropriate CAPAs.
Help train/prepare Stoke GMP employees for regulatory inspections and host GMP and BIMO regulatory inspections, as necessary, and provide input and review of responses to inspection related regulatory agency questions.
Establish and oversee Stoke’s Quality / Regulatory intelligence process to ensure that regulations, standards, and industry best practices are implemented.
Partner with CMC, QA, Regulatory Affairs and Program Teams to ensure Quality strategies support overall development and commercial strategy.
Champion Stoke’s Quality culture.
Lead, mentor, and develop a small team of quality professionals responsible for the administration and management of Stoke’s QMS and compliance management program.
Provide expert oversight in guiding remediation and regulatory communications.