QA Team Lead, Compliance - Operations (Philadelphia, PA)
AstraZeneca

Job Info

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Do you have expertise in, and passion for QA and Compliance? 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.

As the QA Team Lead, Compliance, you will be responsible for maintaining the License to Operate (LTO) for products and processes manufactured at the facility; including interpretation of internal quality standards and external regulatory requirements for the manufacturing of a biologic combination product. You will be a leader in the organization, providing mentorship to other functional teams in Quality, Compliance, and Operational Risk.

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.

Main Responsibilities:

• Ownership and continuous improvement of the following business processes: Self-Inspections, External Inspections, Regulatory Surveillance, Quality Management Review, Annual Product Quality Review, Internal Quality Standard Assessments, Device & Combo Products, Validation Support, Site Data Integrity Program, Issue Management and Recalls
• 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.
• Develops personnel through training, mentoring, coaching, and conducting the annual performance development cycle.
• Ensures growth of the team by identifying areas for staff development and engaging in succession planning.
• Manages the schedule, recruiting, and hiring of open roles.
• Utilizes Lean principles and approaches, such as problem-solving, 5S, and visual management.
• Becomes actively involved in daily operations when required to meet schedules or to resolve complex problems.
• Provides guidance to staff concerning the US and international regulations and compliance issues.
• Leads the planning and execution of internal & external regulatory inspections (FDA, EMA, MHRA, etc).
• Establishes departmental objectives ensuring alignment with Corporate/Site Goals, and departmental budget.
• Maintains responsibility for the generation of Product Quality Review
• Works directly with the Validation department to provide QA support for the development, execution, and review of validation life cycle documents.

Minimum Requirements:

• Bachelor of Science in Biology, Chemistry, Engineering or related fields
• 7+ years of proven experience in the Biopharmaceutical/pharmaceutical industry, with at least 4 years in Quality-related functions
• 3+ years of supervisory/managerial experience in a Quality Assurance or Quality Control function
• Ability to use electronic Quality System platforms.
• Extensive knowledge of current Good Manufacturing practices and technical aspects of the supported business processes are required.
• Strong regulatory and compliance experience with an organization such as FDA, MHRA, EMA, ANVISA, HC, and KFDA.
• Effective communication, supervisory and interpersonal skills are required.
• Working knowledge of Lean manufacturing principles.

Desirable

• A graduate degree is desirable.
• Six Sigma Certification

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.

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