QA Team Lead (Source, Release & Deliver) - Operations (Philadelphia, PA)
Do you have expertise in, and passion for Quality Assurance? Would you like to apply your expertise to impact the Quality organization in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the global leading pharmaceutical companies.
In this role as the QA Team Lead (Source, Release, and Deliver), you will be assuring the quality of materials sourced by the PA facility to manufacture and release Live Attenuated Influenza Vaccine (LAIV). This position interprets and implements scalable solutions for the End to End (E2E) supply of Manufacturing Components, Raw Materials, Excipients, Drug Substance (DS) and Drug Product (DP) and is responsible for the final release of Drug Product to the US market, including Lot Release Protocol submission to the FDA.
This role partners closely with Qualified Persons (QP) in the UK and EU to ensure timely release of DP to those markets and working directly with Operations, Supply Chain, Global Logistics, Global Supplier Quality, and Quality Control to maintain adherence to internal quality standards & regulatory requirements.
The Philadelphia, PA site manufactures a life-saving influenza vaccine. Our product is aseptically filled into sprayers for nasal administration. The site consists of two geographic locations - a facility at Red Lion Road in NE Philadelphia has about 140 full-time employees and the Bensalem storage and distribution facility has about 5 employees. The facilities are about 8 miles apart and both are situated close to I-95, the city of Philadelphia, and Philadelphia International Airport. Our product is sold in the US, UK and other countries. Operations continue year round, with the production season being in the summer (typically May – August).
Our site is highly collaborative where we show our Philly pride in all we do. We work closely together, always striving to be better every day. We have a network of employee teams who deliver many kinds of employee engagement activities, from our famous Wingbowl, to inclusion events, a site picnic, community outreach, health and wellness activities, and a green team.
- Manage Quality, Compliance, and Operational risks via ownership and continuous improvement of the following business processes:
- Material Release
- Drug Substance Release
- Lot Release Protocol Submission
- Drug Product Release
- Supplier Quality Agreements
- Internal Quality Agreements
- Supplier Complaints
- Third Party Supply
- Sample Management
- Warehousing and Distribution Support
- Supervises team and associated business processes by applying the Business Process Management (BPM) framework to set priorities, balance resource workload, support/empower decision making, and build optimized process networks.
- Provides leadership and mentorship to cross-functional working team(s) to ensure compliance of Source, Release and Deliver business processes.
- Becomes actively involved in daily operations when required to meet schedules or to resolve complex problems.
- Executes release processes utilizing detailed process flows, product disposition, timely decision making, managing and measuring work and performance management
- Supports oversight of external suppliers via coordination with internal groups such as Supply Chain, Procurement, Global Supplier Quality, and Global Logistics.
- Develops personnel through training, mentoring, coaching and conducting annual performance development cycle.
- Ensures growth of the team by identifying areas for staff development and engaging in succession planning.
- Manages the scheduling, recruiting, and hiring of open roles.
- Utilizes Lean principles such as problem solving, 5S, and visual management.
- Provides mentorship to staff with respect to US and international regulations and compliance issues.
- Bachelor of Science in Biology, Chemistry, Engineering or related fields
- 7+ years of proven experience in the Biopharmaceutical/pharmaceutical industry, with at least 5 years in Quality-related functions
- 3+ years of supervisory/managerial experience in a Quality Assurance or Quality Control function
- Experience in developing and maintaining Lot Release Systems.
- In depth experience with electronic Quality System platforms and Enterprise Systems.
- Extensive knowledge of current Good Manufacturing practices and technical aspects of supported area are required.
- Strong regulatory and compliance experience with organization such as FDA, MHRA, EMA, ANVISA, HC, and KFDA.
- Effective communication, supervisory and interpersonal skills
- Working knowledge of Lean manufacturing principles.
- Graduate degree is desirable
- Six Sigma Certification
- Experience working as a Third Party Supplier
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.
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.