Manager, Site Operations Quality Systems

Manager, Site Operations Quality Systems

Introduction to role

The Manager, Site Operations Quality Systems is responsible for developing and executing initiatives and projects that contribute to the Site Operations Department Compliance Management strategy. This role involves developing, implementing, and continuously improving quality processes and systems to support pharmaceutical, biotechnology, or other regulated product manufacturing. The manager collaborates cross-functionally to address quality issues, ensures adherence to GMP requirements, and drives a culture of quality throughout the organization. This role is critical in ensuring product quality, regulatory compliance, and continuous improvement to support the organization’s operational and strategic objectives. The Manager must look at the company objectives as they pertain to the Site Operations department and develop plans, policies and procedures for compliance management. The Manager will also collect and compile data, lead investigations and participate in meetings that discuss the overall adherence to the Oncology R&D compliance program. This role will interface closely with the Quality Assurance department and will also be the Functional Lead in all inspection and audit response activities. This role will seek and coordinate training opportunities, support change management, and ensure audit readiness in the Gaithersburg Site Operations organization.

Accountabilities

• Provide hands-on management of the GMP Quality Management System (QMS), including documentation control, and metrics reporting.

• Lead and participate in and approve GMP laboratory or process deviations, including laboratory investigations, change management, deviations, CAPAs (Corrective and Preventive Actions), risk management, and internal audits.

• Lead the review and approval of GMP quality system documentation, including SOPs, Guidance documents, Work Instructions and Validation protocols.

• Ensure compliance with applicable regulatory requirements and industry standards for GMP.

• Ensure continuing suitability and effectiveness of the quality management system, product quality, and GMP/GDP compliance through participation in management reviews and through advocating continual improvement.

• Prepare management reports regarding compliance operations and progress and discuss emerging compliance issues with management.

• Walkthrough partner for all site related GMP self-inspections.

• Collaborate with GMP manufacturing, supply chain, other R&D sites, and other cross-functional departments to align quality objectives with business goals.

• Lead gowning training for colleagues and business stakeholders as required.

• Provide general support related to regulatory authority inspections as required.

Essential Skills/Experience

• Bachelor's degree in a science related field (e.g., biology, chemistry, engineering) with 3+ years of cGMP experience in GMP-regulated industries with a focus on quality systems management    -OR- a Master’s degree in a science related field (e.g., biology, chemistry, engineering) with 2+ years of cGMP experience in GMP-regulated industries with a focus on quality systems management

• Strong verbal and written communication skills, organizational, presentation, and analytical ability

• Experience with electronic quality system platforms and quality tools

• Proven ability to work with cross-functional teams and prioritize tasks in a dynamic environment

• Flexibility, fast turnaround, excellent technical skills and high motivation to fulfilling requests to meet critical timelines supporting the work of others

• Experience with Microsoft SharePoint and MS Office applications, Adobe Pro, EQV/ECMS, SABA Cloud, SAP

• Experience in managing regulatory health authority GMP Inspections

• GMP Audit expertise

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we follow the science to push boundaries. Our commitment to Oncology is driven by our ambition to eliminate cancer as a cause of death. With cutting-edge science fused with the latest technology, we aim for breakthroughs that transform medicine. Our collaborative research environment unites top medical centers worldwide to expedite research in hard-to-treat cancers. Join us to build a rewarding career dedicated to improving millions of lives.

Ready to make a difference? Apply today!

The annual base pay (or hourly rate of compensation) for this position ranges from $85,690 to $128,534. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.