Quality Control Director- West Chester, OH

Would you like to apply your expertise to impact the Quality Operations in a company that follows the science and turns ideas into life changing medicines? A place to take Quality seriously – we draw learnings from others, to develop and understand what it takes to drive our modern mindset forward. Here you’ll feel empowered to step up, follow the science and evidence to make decisions that put patients first.

Our West Chester Supply Site is a multifaceted and growing manufacturing site within the AstraZeneca Global Operations network and is located just north of Cincinnati, Ohio. In addition to serving as the global COVID vaccine production site for AstraZeneca, the West Chester site encompasses Bulk API Microsphere manufacturing, Aseptic Pharmaceutical Formulation, multi-line Isolator/Barrier Vial and Syringe Filling, and specialty Packaging Operations for Vials and Auto-Injectors that supports growing franchises in Diabetes and Respiratory.  Our site is one of 30 production facilities in 18 countries with over 700 people collaborating to connect powerful medications to patients in more than 60 countries around the world. We focus on providing a collaborative environment where everyone feels comfortable and able to be themselves. Being able to bring your full self to work every day is at the core of AstraZeneca’s priorities. On-site amenities include a Health and Wellness clinic, as well as a Cafeteria Grille serving breakfast and lunch items for employees and guests.

The Quality Control Director will manage the activities and systems within the West Chester QC Laboratories to ensure compliance with cGMP, corporate standards, and regulations in global markets served. This role will also provide technical assistance to the PETs, technical groups, and the AstraZeneca network. In addition, the role will represent AstraZeneca in various industry groups dealing with analytical, microbiological and general laboratory issues.

What you’ll do:

• Provide leadership and direction for Safety, Health and Environmental initiatives in the QC laboratories in accordance with corporate goals and standards.
• Ensure cGMP Compliance for the systems and processes within the QC Analytical &
• Microbiology Laboratories. Maintain a cGMP compliant laboratory.
• Provide strategic and tactical direction and vision for ongoing and new projects within the QC Labs and manufacturing systems in accordance with PET and QA goals.
• Provide strategic direction and vision for all US and Global Laboratory system initiatives in accordance with corporate direction and as mandated by federal regulations.
• Manage the development and validation of analytical methodology for new and existing products (USP, EP, and so on, methodology).
• Evaluate and implement “state of the art” analytical instrumentation and methodology.
• Participate in FDA, EMEA and other Regulatory agency inspections and provide response to their questions.  Interact, on behalf of the QC Laboratories, with FDA, EMEA, TURKISH MOH, Canadian and all other foreign regulatory agency inspections.
• Assist in the preparation and review of NDAs and SNDAs and International submissions.
• Provide leadership and direction, as well as defined goals and objectives for direct reports and objective reviews of performance.
• Manage and develop capital and expense budgets for the QC Laboratories.

Essential for the role:

• Bachelor’s degree in Chemistry, Biology, Microbiology or related science field.
• Minimum of 10 (ten) years of pharmaceutical industry experience with 7+ years of relevant Laboratory Experience including supervision (for example Pharmaceutical, Bio Technology)
• Strong leadership, interpersonal, and management capabilities.
• Strong technical and problem solving capabilities.
• Demonstrated knowledge of cGMP as defined by 21CFR, Combination Drugs and EU Regulations
• Strong project management skills.
• Demonstrate understanding of Analytical and Microbiology laboratory regulatory issues.

Preferred Requirements:

• Cross functional and diverse experience within various Quality disciplines (Ex. QA, Compliance, Validation, etc…) or within other areas of the organization (Ex. Operations, OpEx, etc…)
• Lean Six Sigma
• Multiple Site Experience
• Lean Laboratory or similar program implementation success

Why AstraZeneca

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Interested? Come and join our journey!

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.

Find out more on Social Media:

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About Operations https://www.youtube.com/watch?v=gak5Ham8oUw

Date Posted

Closing Date

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.