Site Quality Director

• Ensure all finished products intended for use in the market are safe and effective as per cGMP requirements, regulatory commitments, AZ policies & procedures and site SOPs.
• Set site quality goals, objectives and strategic direction in alignment with Global Radio Conjugate Quality goals.
• Track, trend, maintain and report all Quality and business metrics to monitor and action all QA & QC compliance activities.
• Prevent Quality or regulatory non-compliance issues which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the quality, financial performance and reputation of the company.  Non-compliance issues are to be addressed via corrective and preventive actions (CAPA).
• Ensure rationalization and management of Quality processes, operations and systems. Perform gap analysis to plan actions for continuous improvements.
• Resource planning and monitoring for head count projections, manage site budget, capital budget and manage organizational development.
• Responsible for site lean design and execution of continuous Quality & Compliance improvement initiatives, standardizations and efficiency gains to enhance compliance, drive efficiencies and reduce cost of poor quality.
• Coach and develop direct and indirect reports, as appropriate, through ongoing, example-based performance feedback, annual performance reviews and the provision of training and development opportunities.
• Performs all work in support of our Corporate Values and Behaviors and in accordance with established regulatory and compliance and safety requirements.
• Ensure the raw material, packaging material and finished products are tested and released in accordance to approved specification and test methods in a timely manner as per the site commits and support business needs.
• Ensure the health authority and Annex 1 requirements at the site are met for sterile products.
• Support the development of site strategy to respond to audit observations, inspection findings and implement corrective actions.
• Create and maintain 24/7 inspection readiness at the Hamilton site.
• Be a solution-oriented leader and role model AZ behaviors.
• This is a supervisory position with direct reports; therefore, this position will establish goals and objectives, prepare performance appraisals, monitor/review work product and coach/mentor direct reports.
• Other duties as required/assigned.

Minimal Qualifications:

• Bachelor’s degree in chemistry, pharmacy or relevant engineering or life science field is required. Candidates with advanced degrees are highly preferred.
• This position requires a minimum of fifteen (15) years of experience (10 years + 5 years in leadership capacity) in pharmaceutical quality management, and minimum five (five) years of experience in leadership role.
• Significant experience in radio conjugates is preferred with experience in the review and auditing of executed batch records, material release records, and qualification protocols.
• A strong knowledge of GMP’s in both domestic and international regulatory environments is required.
• Excellent and detailed knowledge of Quality/Compliance processes and programs for development and commercial products including regulatory requirements on a global level; working knowledge of safety and environment regulations and guidelines are also required.
• Strong comprehensive knowledge of USFDA 21 CFR regulations Part 11: EC/ER requirements, GMP requirements of various regulatory bodies – USFDA/ MHRA/ EU GMP/ PMDA.
• Strong comprehensive knowledge of ICH Guidelines, FDA and Health Canada Regulations.
• A proven ability to lead, manage and motivate people with a variety of skill sets is required.
• Strong organizational, interpersonal and communication skills are required.
• Ability to work effectively in an international matrixed organization is strongly preferred.
• Must be on-site (Hamilton, ON) for Quality support of ongoing activities.  Role requires off-shift, evening and weekend support.
• Knowledge of quality operations and compliance of clinical and commercial aseptic manufacturing.
• Must possess excellent written, organizational and communication skills.

At AstraZeneca, we foster a collaborative, innovative culture with opportunities to work across teams, functions, and geographies.   You’ll join a collaborative, innovative community with opportunities to work across teams, functions, and geographies—where your ideas move fast and your impact is visible. We’re committed to sustainability and equity, taking bold action on climate, access to healthcare, and disease prevention.