Senior Auditor - RDQA Clinical Quality Audit (all genders)
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
People. Passion. Possibilities. Three words that make a world of difference.
More than a job. It's a chance to make a real difference.
Welcome to AbbVie! As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!
Together, we break through – as Senior Auditor - RDQA Clinical Quality Audit (all genders) (full-time)
In this role, you are primarily responsible for the execution of the Clinical audit program, including scheduling, planning, reporting and resolution of Clinical audits. You ensure also alignment with RDQA policies and procedures wherever possible and take the lead in the development and implementation of the Clinical Audit quality system. Recognized as Subject Matter Expert, you will provide support on GCP and quality topics and advice business partners to ensure compliance with worldwide requirements and expectations.
Could be based in the following European locations – UK/ Germany/ Italy/ France/ Spain
Make your mark:
Assure quality and compliance in a regulated environment that includes worldwide regulations, country specific and other applicable standards and AbbVie policies as well as procedures by continuous evaluation of Clinical processes through audit and QA oversight activities.
Take a lead in the Clinical audit program by planning and executing all types of clinical audits and working with auditees to resolve any non-compliance identified. Regularly taking the lead in more complex/challenging audits.
Manae risk-based assessments to identify potential audits.
Advance the AbbVie Quality System through leading and/or contributing to the development and implementation of systems and processes required to support global quality assurance requirements.
Contribute to continuous improvement initiatives to help assure compliance regulations and corporate policies.
May act as Audit Lead/SME for an assigned audit type (responsible for maintaining standards including tools/templates and guidance documents and participate in onboarding new auditors for that audit type).
Mentor Clinical Audit staff and participate in and support GCP inspections, as required.
Provide support and consultation to RDQA and business partners with regards to Clinical Quality and GCP regulations (Recognized as a SME).
Qualifications
This is how you make a difference:
Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
3-5 years of working experience in the biopharmaceutical industry (Quality Assurance and/or Clinical Research Development) or with a regulatory authority
3-5 years of working experience in Clinical Quality Auditing
High level of awareness and understanding of clinical trial regulations (e.g., ICH-GCP, EU Clinical Trial Directive/Regulation) and industry best practices
Strong analytical skills and the ability to draw conclusions from presented data
Ability to work self-sufficiently, effectively and efficiently promote a dynamic environment
Flexibility to adapt to changing assignments and ability to effectively prioritize
Good project management, interpersonal, and communication skills with ability to work as part of a team
Willingness and ability to perform international travel
Language proficiency in English oral and written.
What we offer you:
with a diverse work environment where you can have a real impact
with an open corporate culture
with an attractive salary
with an intensive onboarding process with a mentor at your side
with flexible work models for a healthy work-life balance
with a corporate health management that offers comprehensive health and exercise programs
with company social benefits
with a wide range of career opportunities in an international organization
with top-tier, attractive development opportunities
with a strong international network
At multiple times, we have been globally recognized as a 'Great Place to Work' and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.
At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.
Any questions? Feel free to email us at [email protected] – We look forward to hearing from you!
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
About the job
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Senior Auditor - RDQA Clinical Quality Audit (all genders)
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
People. Passion. Possibilities. Three words that make a world of difference.
More than a job. It's a chance to make a real difference.
Welcome to AbbVie! As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!
Together, we break through – as Senior Auditor - RDQA Clinical Quality Audit (all genders) (full-time)
In this role, you are primarily responsible for the execution of the Clinical audit program, including scheduling, planning, reporting and resolution of Clinical audits. You ensure also alignment with RDQA policies and procedures wherever possible and take the lead in the development and implementation of the Clinical Audit quality system. Recognized as Subject Matter Expert, you will provide support on GCP and quality topics and advice business partners to ensure compliance with worldwide requirements and expectations.
Could be based in the following European locations – UK/ Germany/ Italy/ France/ Spain
Make your mark:
Assure quality and compliance in a regulated environment that includes worldwide regulations, country specific and other applicable standards and AbbVie policies as well as procedures by continuous evaluation of Clinical processes through audit and QA oversight activities.
Take a lead in the Clinical audit program by planning and executing all types of clinical audits and working with auditees to resolve any non-compliance identified. Regularly taking the lead in more complex/challenging audits.
Manae risk-based assessments to identify potential audits.
Advance the AbbVie Quality System through leading and/or contributing to the development and implementation of systems and processes required to support global quality assurance requirements.
Contribute to continuous improvement initiatives to help assure compliance regulations and corporate policies.
May act as Audit Lead/SME for an assigned audit type (responsible for maintaining standards including tools/templates and guidance documents and participate in onboarding new auditors for that audit type).
Mentor Clinical Audit staff and participate in and support GCP inspections, as required.
Provide support and consultation to RDQA and business partners with regards to Clinical Quality and GCP regulations (Recognized as a SME).
Qualifications
This is how you make a difference:
Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
3-5 years of working experience in the biopharmaceutical industry (Quality Assurance and/or Clinical Research Development) or with a regulatory authority
3-5 years of working experience in Clinical Quality Auditing
High level of awareness and understanding of clinical trial regulations (e.g., ICH-GCP, EU Clinical Trial Directive/Regulation) and industry best practices
Strong analytical skills and the ability to draw conclusions from presented data
Ability to work self-sufficiently, effectively and efficiently promote a dynamic environment
Flexibility to adapt to changing assignments and ability to effectively prioritize
Good project management, interpersonal, and communication skills with ability to work as part of a team
Willingness and ability to perform international travel
Language proficiency in English oral and written.
What we offer you:
with a diverse work environment where you can have a real impact
with an open corporate culture
with an attractive salary
with an intensive onboarding process with a mentor at your side
with flexible work models for a healthy work-life balance
with a corporate health management that offers comprehensive health and exercise programs
with company social benefits
with a wide range of career opportunities in an international organization
with top-tier, attractive development opportunities
with a strong international network
At multiple times, we have been globally recognized as a 'Great Place to Work' and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.
At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.
Any questions? Feel free to email us at [email protected] – We look forward to hearing from you!
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html