Compliance Investigation Manager jobs in the United States

Compliance Investigation Manager oversees investigations of alleged violations of the corporation's ethical standards or non-compliance with applicable laws, regulations and corporate policy. Assigns investigations to professional staff and ensures that staff follows approved investigation procedures. Being a Compliance Investigation Manager ensures that investigations are properly documented and reports findings to authorities as needed. Helps develop compliance training and recommends proactive measures that will reduce the risk of future violations or non-compliance. Additionally, Compliance Investigation Manager requires a bachelor's degree of related area. Typically reports to a head of a unit/department. The Compliance Investigation Manager typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. To be a Compliance Investigation Manager typically requires 3+ years of managerial experience. (Copyright 2024 Salary.com)

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Associate Director, Audit Quality Assurance
  • 10001183 - Compliance Manager
  • Gaithersburg, MD FULL_TIME
  • 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.

  • 5 Days Ago

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Compliance Manager
  • Spruce Street Compliance
  • Washington, DC FULL_TIME
  • Spruce Street Consulting LLC is Pennsylvania’s premier political compliance firm. Our firm is committed to supporting progressive causes and candidates nation-wide. This position will report to the Pr...
  • 17 Days Ago

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Compliance Manager
  • Spruce Street Compliance
  • Philadelphia, PA FULL_TIME
  • Spruce Street Compliance is political and nonprofit compliance consulting firm based out of Philadelphia, PA and Washington, DC. Our firm is committed to supporting progressive causes and candidates n...
  • 17 Days Ago

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Compliance Investigation Analyst, Hybrid
  • University of Maryland Medical System
  • Linthicum Heights, MD FULL_TIME
  • Job DescriptionGeneral SummaryUnder the supervision of the Director of Compliance, the analyst will manage, develop, implement and monitor policies, procedures, processes, training, corrective action ...
  • 7 Days Ago

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Investigation Manager
  • State of Missouri
  • Jefferson City, MO FULL_TIME
  • This position will be filled at a salary no higher than the posted maximum salary. Job Location: Central Office, 105 West Capitol Avenue, Jefferson City, MO Why you’ll love this position: The investig...
  • 9 Days Ago

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Investigation Manager
  • Rockford Public Schools
  • Rockford, IL FULL_TIME
  • JobID: 15499 Position Type: Non-Certified Support/Investigator Date Posted: 4/7/2022 Location: Administration - Legal ROCKFORD PUBLIC SCHOOL DISTRICT #205 Job Description Job Title: Investigation Mana...
  • 10 Days Ago

Income Estimation for Compliance Investigation Manager jobs
$147,035 to $178,924

Career Path for Compliance Investigation Manager