Compliance Manager manages the compliance programs, policies, reporting, and practices for an organization or business. Ensures that all activities follow regulatory requirements related to the governance of the organization as well as any industry-specific or location-specific laws. Being a Compliance Manager oversees internal controls and auditing systems that monitor and report on regulated activities and processes. Implements risk-based compliance testing of existing procedures and controls to identify, detect, and correct noncompliance. Additionally, Compliance Manager evaluates and implements changes to compliance processes due to new or amended regulations. Delivers communication and training initiatives that inform stakeholders about compliance requirements. Requires a bachelor's degree or equivalent. Typically reports to a director. The Compliance Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Compliance Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Job Title: Associate Director, Audit Quality Assurance
Location: Gaithersburg US or Mississauga CA (3 days on site)
Join us in R&D Quality Assurance as an Associate Director! You will lead a variety of GCP & GVP audits with a focus on Digital Health, Cell Therapy, Precision Medicine and Medical Devices. The ideal candidate is a passionate, self-motivated, and diligent team player who is committed to the success of our business. If this sounds like you then AstraZeneca might be the one for you!
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 approach for the benefit of our patients.
Accountabilities:
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 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 GCP/GVP inspections
Collaborates with Quality Assurance lead, to handle 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 collaborators
Maintains knowledge of relevant industry information affecting quality and compliance arena
Leads training for colleagues and business partners 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 GCP/GVP/quality system expert
Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
Essential Skills/Experience:
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 running & using technology
Ability to maintain and create professional networks with collaborators
Supplier qualification
Desirable Skills/Experience:
Expertise in Data Insights, IVDR/SaMD, Digital
Project management experience
Experience in leading regulatory health authority GxP Inspections
Key Account management
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 bold world.
Why AstraZeneca?
Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025.
A place built on courage, curiosity and collaboration. we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team.
Pioneers of collaborative research we have built an unrivalled scientific community both internally and externally. Fusing academia and industry, we have united some of the world's foremost medical centres. Working seamlessly and inclusively, together we expedite research in some of the hardest-to-treat cancers.
Have the opportunity to build a rewarding and meaningful career as part of the team committed to improving the lives of millions with cancer.
Are you ready to make a difference? Apply now!
AstraZeneca embraces diversity and equality of opportunity. We are 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 comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.