At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Quality Control Lead in Philadelphia, PA, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast-paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

The Quality Control Lead is responsible for all assigned aspects of QC at the Philadelphia, PA Manufacturing Center, including the testing of raw materials, manufacturing/packaging components, validations samples, in-process samples, reserves/retains and microbiology samples in support of clinical and commercial production.

Responsibilities:

• Adhere to all environmental, health and safety SOPs, equipment, policies and procedures including any department specific requirements and drives compliance to these through their organization.
• Oversight of QC quality systems (e.g. MODA, GQCLIMS, etc.)
• Oversight of aseptic operations.
• Oversight of environmental and critical utility monitoring.
• Responsible for development of an annual operating budget exceeding $2MM and maintaining expenses within the plan.
• Develop self, direct reports and site high potential employees.
• Regularly interacts with Manufacturing, Quality Assurance, Supply Chain, Operations Strategy senior management on matters concerning several functional areas and/or customers.
• Drive continuous improvement culture within the PA Manufacturing via DMAIC, Lean and employee engagement.
• Maintains communication with and ensure products are provided to internal customers on time so that product quality, yield, operating costs and process efficiencies are met.
• Responsible for ensuring the quality and quantity of work produced, staffing requirements, budgets, costs, methods, maintenance of discipline, transfers, promotions, salary changes, terminations and performance standards.
• Represent site as a member of the Stability Committee, QC Council and the Vaccine Specification Working Committee.
• Ensure robust QC planning, metrics and project management occur in support of department, site and company goals.
• Provide leadership, direction, and mentoring to ensure that the QC organization is successful in meeting the quality and manufacturing objectives in support of site goals. 
• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.  Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.   Report potential issues of non-compliance.

Qualifications:

Education:

• Bachelor’s Degree in Microbiology, Biological Sciences or related discipline.

Required:

• Minimum of ten (10) years of experience in biopharm, medical device, or pharmaceutical manufacturing.
• Minimum of five (5) years of supervisory experience.
• Ability working in a matrix environment.
• Excellent communication skills (with staff, peers and upper management) and ability to develop rapport with other functional leaders to influence decision-making.
• Excellent leadership skills including sponsorship/leading projects with broad scope, cross-functional/site nature, and an impact outside own department while promoting teamwork between departments and sites.
• Ability to do analysis of trade-offs between business objectives – ability to think systemically.
• Embraces change, challenges status quo and makes recommendations for improvements to products and processes.  Creates tools that help simplify job tasks and shares these with others.
• Requires the ability to change the thinking of, or gain acceptance of, others in sensitive situations.
• Strong problem solving, negotiating and presentation skills.
• Ability to interpret and analyze statistical data and information and financial reports, understand and resolve technical difficulties, interface with internal engineering/technical experts and external technical representatives, and manage multiple priorities in a manufacturing plant setting.
• Proven track record in managing a diverse, fast paced organization.

Preferred:

• Advanced Degree preferred
• Minimum of three (3) years experience in aseptic manufacturing leadership preferred.
• Thorough understanding of electronic data integrity principles.
• Method development/optimization experience.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

Date Posted

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AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.