Head of Quality Assurance
Milestone Pharmaceuticals is an equal opportunity employer. This position is based in Montreal, Quebec, Canada; or Charlotte, NC
The GxP Quality Leader can be Senior Director or VP level, depending on experience. This position is responsible for organizing, managing and controlling all aspects of pharmaceutical clinical and manufacturing quality assurance and compliance activities, and for ensuring that established regulatory requirements and policies are met. The GxP Quality Leader reports to the Vice President Regulatory Affairs & Quality Assurance with dotted line reporting to the Chief Executive Officer.
Main Duties and Responsibilities
- Together with Sr. Management, drives a culture of quality throughout the organization;
- Defines globally-coordinated clinical/CMC quality assurance and compliance objectives, quality assurance systems, quality agreements, training programs and policies;
- Organizes, manages and evaluates all clinical/CMC vendors and clinical sites;
- Ensures compliance with relevant Company, local law and regulatory authority requirements;
- Evaluates clinical/CMC audit findings and responds to these findings with process and procedure improvements that drive quality system efficiency and effectiveness;
- Performs risk assessment and supports risk-based decision-makingregarding projects and resources;
- Provides clinical/CMC quality assurance expertise, coaching and mentorship to all operating groups through active participation in cross-functional teams;
- Provides clinical/CMC quality support and assistance to RegulatoryAffairs;
- Maintains relationships with regulatory authorities and provides support to answering Regulatory (FDA, EMA, etc.) questions/comments during filing review;
- Provides support to internal and external Company initiatives as required, including participation in due diligence processes, R&D development programs, and third-party sourcing;
- Participates in the development and implementation of processes methods, procedures and regulations necessary for the efficient operation of the department;and
- Able to travel as needed, and participate in audits as required, within North America and abroad.
Education, background, knowledge and skills
- Fifteen (15) plus years of pharmaceutical industry experience in quality assurance;
- Advanced degree preferred (M.S. or Ph.D.) in Life Sciences, or equivalent;
- Experience as a GxP leader for a drug development program(including Phase II studies);
- Extensive knowledge of global GMP, GCP and GLP;
- Proficiency with: pharmaceutical product development and clinical study processes, quality assurance and compliance techniques and U.S. and European regulations;
- Small company experience utilizing a highly outsourced model;
- NDA filing and approval experience highly preferred; and
- Experience with mattersof Corporate Commercial Compliance is a plus.
- An ethical,resourceful, confident professional with strong problem/conflict solving,verbal and writtencommunication and interpersonal/team skills;
- A natural partner and educator with the capability to firmly enforce standards;
- Strong initiative and organizational skills with the ability to multi-task and prioritize assignments;and
- Demonstrated ability to identify and resolve issues, meet deadlines and manage crises..
Milestone Pharmaceuticals is a developmental pharmaceutical company which is developing novel small molecule therapeutics for transient cardiovascular conditions. Milestone offers an exciting and entrepreneurial environment, and a competitive compensation and benefits package.