Associate Director Labs QA Audit

Found in: Jooble US O C2 - 2 weeks ago

Waltham MA, United States Professional Diversity Network Full time

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

Audit team - GCP, GVP, GRP, LabGCP including strategy where applicable
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
Leads Supplier qualification activities (Operational Due diligence ODD) as assigned
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.
Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines
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
Experience in pharmaceuticals or a related industry
Fluent in written and spoken English
Skilled at managing & using technology
Ability to maintain and create professional networks with stakeholders
Project management experience
Experience in managing regulatory health authority GxP Inspections
Key Account management
Audit expertise
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 welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
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. 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. #

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