Associate Quality Director / Quality Director - Newark, DE - Global Operations

Astrazeneca Newark , NJ 07101

Posted 5 months ago

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As an Associate Quality Director / Quality Director in Newark, DE, 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.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world 20% of our global workforce. With 30 production facilities in 18 countries we're focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that's full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive 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

The successful candidate will be hired at either the Associate Quality Director level or the Quality Director level based on skillls and experience.

The Associate Quality Director / Quality Director is accountable for all Quality Assurance (QA) activities and decisions (end-to-end) that directly support execution of the PET mission. These activities and decisions include: Batch Records, Change control and documentation, Equipment and process validation, Deviation investigations, SOPs, Regulatory interactions.

  • This leadership role, reporting to the Sr. Director, QA is the single point of contact for all QA matters related to PET execution (quality, supply, and cost) and the primary link between the PET and other QA/QC functions.

  • Accountable for all QA decision-making in the PET; works directly with the PET leader and other PET members to deliver all PET objectives.

  • Provides direction, development, and performance management to the Quality professionals supporting the PET; serves on the site Quality Assurance Leadership Team (QALT).

  • Performs (as needed) the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and the equipment and facilities utilized by the PET: Change Requests, Batch Release decisions including Stop Shipments, Quality Investigations (Deviations, Product Complaints), Validation Plans, Protocols and Reports, Standard Operating Procedures.

  • Collaborates with Quality facilitators and Quality professionals from other PETs to ensure consistent application of the key quality systems across all PETs.

  • Interfaces with the Site Support Groups on improvement projects (capital and non-capital) that impact the PET, and proactively ensures GMP compliance during the planning, execution, and closeout phases of these projects.

  • Provides support to internal audits and regulatory agency inspections for queries relating to process execution activities.

  • Ensures that PET complies with all GMP Compliance and Regulatory requirements by providing proper coaching, mentoring and consultation to the PET leader and PET members.

  • Ensures that the QA processes including batch record review, product disposition and quality issues resolutions are executed to maintain the flow of products and documents to meet PET objectives.

  • Serves as liaison in discussions and agreements with, and ensures timely communication to, other QA functions at the Site (Compliance and QC Labs).

  • Collaborates with other members of the PET to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices.

  • Manages the budget of the team to ensure delivery of annual budgetary commitments.

The Associate Quality Director will have extensive experience operating in a GMP environment and will have demonstrated the following capabilities:

  • Robust knowledge of regulatory requirements and pharmaceutical quality systems

  • Strong leadership capabilities, values, and behaviors

  • Strong understanding and application of quality risk management principles

  • Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration

  • The incumbent may be new, or relatively inexperienced in certain aspects of the role (e.g. management of personnel, management of budgets etc.).

The Quality Director will be highly experienced and capable in all major responsibilities of the role.

  • Develops and maintains a high level of understanding of the technical production process, equipment and systems being utilized within the Process Execution Team (PET).

  • Collaborates with counterparts from other sites and functions to ensure consistent application of the key quality systems and continuous improvement of processes.

  • Serves as a liaison with other global AZ supply sites and quality organizations; may also serve as QA representative to U.S. product supply teams.

  • Participates on internal task forces and may also contribute to external industry associations that evolve and transform the quality assurance discipline

  • High level of proficiency in problem solving and quality risk management principles.

  • Training and mentoring of other members of the organization.

  • Strong performance history of consistently meeting and exceeding expectations

  • A passionate champion of quality and compliance; maintaining current knowledge of regulatory and industry trends and actively communicating these to colleagues.

  • Leading/driving step change improvements to quality systems / processes through cross-functional project teams.

  • Expert level understanding of cGMPs and Quality Systems and competency to provide back-up coverage for the Senior Director of Quality as needed.

  • Influencing and negotiation at all levels of the organization: globally and inside and outside of QA to deliver significant improvements in quality/compliance.

Qualifications:

Education:

Associate Quality Director

  • Bachelor's degree (typically in a science or technical field such as Pharmacy, Biology, Chemistry or Engineering).

Required:

  • Prior experience in Operations roles within the pharmaceutical industry (typically 5 or more years).

  • Strong knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies.

  • Prior experience with regulatory agency interactions and compliance procedures.

  • Capability to influence leaders in a matrix environment and the personal conviction to make courageous decisions to ensure patient safety and to protect company reputation.

  • Strong leadership, project management, and technical writing skills.

  • Strong interpersonal, communication, and influencing skills.

Preferred:

  • Prior experience in supervisory/managerial roles.

  • Diverse working experience (e.g. multiple sites or functions both within and outside of Quality).

  • Demonstrated Lean / Manufacturing Excellence knowledge and capabilities.

Quality Director

In addition to the above requirements, the following additional requirements apply:

  • Prior experience in supervisory/managerial roles.

  • Demonstrated Lean / Manufacturing Excellence knowledge and capabilities.

  • Demonstrated ability to lead strategically and align teams to common goals.

  • Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional teams in the US and global.

  • Demonstrated Lean / Manufacturing Excellence knowledge and capabilities.

Preferred:

  • Expert knowledge of global regulatory and cGMP requirements, industry best-practices.

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 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.


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Associate Quality Director / Quality Director - Newark, DE - Global Operations

Astrazeneca