Lead QA Advisor- Gaithersburg, MD
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Lead QA Advisor in Gaithersburg, MD, 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.
Description: The Lead Quality Advisor is the prime source of quality/compliance advice to project teams, or functions, across Pharmaceutical Technology and Development, and Pharmaceutical Sciences. They interpret external regulatory standards and expectations into appropriate quality standards and provide guidance to project teams or functions to ensure overall that compliance with AstraZeneca and Regulatory requirements are met.
The role holder operates independently with minimal supervision. They use risk management to evaluate compliance issues and develop solutions. Their decisions are made against a background of regulations that vary depending on the stage of development and against a set of standards that require interpretation
When working with project/supply chain teams, they are responsible for compliance decisions having a major impact on a portfolio of AZ development projects and therefore AZ’s business and external reputation.
When working with external supplier management they are responsible for evaluating the suitability of suppliers including via audit and on-going Quality Management, thus impacting AZ’s business and external reputation.
- Develop and contribute to the internal and external audit plan and carry-out QA/GMP internal and external audits.
- Responsible for Quality Management of suppliers or contractors delivering services or products to the Pharmaceutical Development Supply Chain. Monitors and improves supplier performance.
- Responsible for the approval/rejection of suppliers and working and partnering with selected supplies to enhance the quality of supplies and services.
- Provide expert support and guidance to Development Functions to satisfy external Regulatory Authority GMP inspections and support implementation of agreed global standards.
- Owner of a number of Quality Management systems systems/processes and lead continual improvement of these systems in line with new GMP regulations.
- Develop and maintain in-depth knowledge of the quality regulations and guidelines applicable to their area.
- Mentor, support and inspire junior colleagues for enhanced individual and team performance.
- Work with the Quality Director to develop and implement global objectives.
- Build and maintain strong customer relationships with other functions whose activities overlap, influence or affect compliance and lead or participate in GxP audits/initiatives with other AZ quality groups.
- Develop solutions to a diverse range of problems that require complex judgements, using highly developed levels of conceptual thought, strategic vision and analysis.
- Ensure appropriate Quality Assurance input to major business improvement projects and lead projects across Pharmaceutical Technology and Development, and Pharmaceutical Sciences.
- Support Issue Management Teams on project specific issues
- Operate confidently as part of a global organisation with an integrated mindset to create an organisation with common processes and ways of working
Minimum Requirements – Education and Experience
- Experience of auditing in a Pharmaceutical environment.
- Appropriate scientific degree with extensive experience (5-10 years) of working within a pharmaceutical GMP environment
- Extensive experience from working in a Quality Assurance function is essential;
- A broad and comprehensive understanding of Quality Systems and GMP
- A comprehensive understanding of the pharmaceutical/drug development process
- Good knowledge and reputation in the QA arena and specifically in GMP matters
Skills and Capabilities
Next Steps – Apply today!
- Excellent team working and networking skills and encourages team effectiveness
- Demonstrates independent judgement and uses risk management in complex situations
- Capable of making decisions, acting courageously and communicating with conviction and inspiration
- Demands excellence (sets high bar) and delivers
- A good communicator with experience of interacting effectively across interfaces
- Builds excellent relationships both internally and with external suppliers or service providers
- Demonstrate drive and energy in the role to make a difference.
- Demonstrates a high degree of personal credibility
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 is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.