ICON plc

Senior Manager, Quality Assurance

ICON plc$100K — $130K *
US-AnywhereRemote in Blue Bell, PA
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a relevant discipline
  • Minimum of 7 years of quality assurance experience in pharma, biotech, or CRO
  • At least 3 years in a management or leadership role
  • Strong knowledge of regulatory compliance (ICH-GCP, FDA)
  • Excellent analytical and problem-solving skills
  • Exceptional communication and interpersonal skills
  • Willingness to travel approximately 35%

Responsibilities

  • Develop and implement quality assurance strategies for clinical trials
  • Conduct thorough quality assessments and regulatory compliance audits
  • Collaborate with cross-functional teams to resolve quality issues
  • Review and approve clinical trial documentation for accuracy
  • Lead and mentor quality assurance staff for continuous improvement

Benefits

  • Comprehensive health and wellbeing programmes including medical, dental, and vision coverage
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training
Full Job Description
Senior Manager, Quality Assurance

As a Senior Manager, Quality Assurance at ICON, you will ensure the quality and compliance of clinical trials, interpreting regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

You will manage quality assurance and compliance activities across your area, ensuring your team delivers to the highest standards.

Key responsibilities include:

  • Developing and implementing quality assurance strategies and processes to support clinical trial activities.

  • Conducting comprehensive quality assessments and audits to ensure compliance with regulatory standards and guidelines.

  • Collaborating with cross-functional teams to identify and address quality issues and implement corrective actions as needed.

  • Participating in the review and approval of clinical trial documentation and data to ensure accuracy and completeness.

  • Providing leadership and mentorship to quality assurance staff, fostering a culture of excellence and continuous improvement.

Your Profile:

You will have a strong background in quality assurance and compliance, with proven management experience and a commitment to quality delivery.

Required qualifications and experience:

  • Bachelor's degree in a relevant discipline

  • Minimum of 7 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a management or leadership role.

  • Strong knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).

  • Excellent analytical and problem-solving skills, with the ability to identify and resolve complex quality issues.

  • Exceptional communication and interpersonal skills, with the ability to collaborate effectively with colleagues and stakeholders at all levels.

  • Willingness to travel as required (approximately 35%)


Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our to read more about the benefits ICON offers.

About ICON plc

ICON plc is a global provider of drug development and commercialisation services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development. ICON has approximately 15700 employees in 40 countries. The company was founded in Dublin, Ireland in 1990 and is headquartered in Leopardstown, Dublin. ICON has been publicly traded on the NASDAQ since 1998.
Learn more about ICON plc
Size
39,300 employees
Market Cap
$16.2 billion
Industry
Net Income
$332.3 million
Founded
2017
5 Year Trend
+26.9%
Revenue
$2.7 billion
NASDAQ

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