Senior Manager / Associate Director, Quality Control
Senior Manager / Associate Director, Quality Control- Frederick, MD
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? Then AstraZeneca might be the one for you!
At AstraZeneca, we continuously forge partnerships that help pursue extraordinary medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe. Working here means being results-oriented, thinking big and working together to make the impossible a reality. We’re passionate about the potential of science to address the unmet needs of patients around the world. We commit to those areas where we believe we can really change the course of medicine and bring big new insights to life. With 30 production facilities in 18 countries we’re passionate about supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Come and thrive in our vibrant, energizing, connected and encouraging 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
Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world. This biologics manufacturing facility makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. It’s challenging but highly rewarding work, involves more than 675 hardworking people throughout the manufacturing lifecycle and supporting office functions. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building events, we take time to recognize our achievements.
The Frederick Manufacturing Center is dedicated to creating a culture of inclusion and collaboration. We host yearly Inclusion and Diversity conferences and have an employee resource group devoted to promoting diversity and inclusion and enhancing employees' professional development through interactive and engaging events and initiatives. We are committed to continuous learning and offer ongoing skill building and training for our staff and encourage additional secondary schooling with tuition reimbursement of 100% up to $10,000 each year. The FMC is also an award-winning employer and has been recognized as a ‘Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’ distinction in 2015 and 2019. Come join our award-wining team and support the manufacture of life-changing medicines for patients across the world.
Reporting to the Director of Quality Control, this position is responsible for microbiological testing and laboratory support of the site with management of approximately 30 direct/indirect employees. The role will form part of the site Quality Control leadership team.
**This is posted at a Senior Manager / Associate Director Level position based on experience**
What you’ll do:
- Responsible for all assigned aspects of Quality Control at the Frederick Manufacturing Center, potentially including the testing of raw materials, in-process, drug substance, drug product, stability and microbiology samples in support of late stage clinical and commercial programs.
- Responsibilities will include oversight of all aspects of Environmental Monitoring, Microbiological testing and QC Sample Management.
- Implement and maintain, as required, QC computerized systems (e.g., LIMS, MODA, lab instruments) and equipment. Maximize operational effectiveness to ensure high-level testing, planning, and computerized system support.
- Ensure robust QC planning, metrics, and analytical tech transfer project management occur in support of department, site and company goals.
- Represent QC department on assigned site governance and operational teams internally, and as an empowered functional representative externally to ensure deliverables are aligned with site business objectives.
Essential for the role
- Bachelor’s Degree in appropriate scientific field. Master’s degree desirable.
- Minimum of 10 years of working within a pharmaceutical GMP environment, preferably within a biologics / large molecule environment.
- At least 5 years of management experience.
- A broad and comprehensive understanding of Quality Systems and GMP. Experience with MODA Software desirable.
- An all-inclusive understanding of the pharmaceutical/drug development process.
- Understanding of Project Management, Supply Chain and LEAN processes
- Proven leadership and excellent communication skills.
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. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next!
Are you ready to bring new ideas and fresh thinking to the table? Wonderful! We have one seat available and we hope it’s yours.
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 phenomenal fit, please share this posting with them.
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 authorisation and employment eligibility verification requirements.