Job Title: Associate Director Labs Quality Assurance Audit

Location: Onsite with Flexibility in Waltham MA or Gaithersburg MD

Job Capsule:

As the independent second line assurance function for R&D, our mission in Quality Assurance is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality mindset for the benefit of our patients.

The Associate Director Quality Assurance LabsQA is responsible for:

• Planning, leading, conducting and reporting audit activities for R&D GxP risk-based audit programs
• Delivery of proactive GxP inspection support and management
• Management of significant CAPAs related to audit and/or inspection findings in collaboration with functions owning the issues.

Typical Accountabilities:

The Quality Assurance GxP accountabilities are split between the QA teams as below ~

• Audit team - GCP, GVP, GRP, LabGCP including strategy where applicable
• LabsQA team - GLP, HBS, GLS, LabGCP, ISO 17025, CLIA including strategy

Audit:

• Plans, leads, conducts and reports audits in assigned GxP areas, and types e.g. investigator site audit, system or process audits and vendor audits.
• Participate in and may lead directed (For Cause) audits.
• Works with contract personnel or consultants to prepare, conduct and report outsourced audits
• Supports Due Diligence activities as assigned
• Leads Supplier qualification activities (Operational Due diligence ODD) as assigned
• Identify and assess gaps during supplier qualification assessments

CAPA:

• Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completion

Inspection:

• Provides QA oversight and/or management of regulatory GxP inspections
• Collaborates with Quality Assurance lead, to manage and prepare for regulatory inspections as assigned including providing training to the organisation as needed.

General Accountabilities:

• Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines
• Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
• Communicates effectively with QA colleagues and business stakeholders
• Maintains knowledge of relevant industry information affecting quality and compliance arena
• Leads training for colleagues and business stakeholders as required.
• Involved in and may lead the development and/or revision of QA processes, projects and tools
• Mentors QA colleagues
• Provides general support related to regulatory authority inspections as and when required
• Provides responsive and proactive quality and compliance advice to defined customers, effectively influence assigned area by being relevant GxP/quality system expert
• Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
• Travel expected

Essential Education, Skills and Experience Required for this Role:

• Degree level education or equivalent experience
• Experience in pharmaceuticals or a related industry
• Excellent analytical, written and oral communications skills
• Fluent in written and spoken English
• High ethical standards, trustworthy, operating with absolute discretion
• Strong collaborative, influencing and interpersonal
• skills – curious to understand business environment
• Skilled at managing & using technology
• Ability to maintain and create professional networks with stakeholders
• Supplier qualification

Preferred Education, Skills and Experience for this Role:

• Project management experience
• Experience in managing regulatory health authority GxP Inspections
• Key Account management
• Audit expertise

Employer of Choice:

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society because AstraZeneca embraces diversity and equality of opportunity.

AstraZeneca is 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 offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a comprehensive benefits package!

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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.

Date Posted

13-Mar-2024

Closing Date

11-Apr-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.