IQVIA

Quality Manager

IQVIA • $86K — $216K *
Durham, NC 27713In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in health sector or related field or equivalent experience
  • Sound knowledge of ICH, GCP, and regulatory requirements
  • Familiarity with drug development processes and pharmaceutical operations
  • Strong organizational, communication, and interpersonal skills
  • Ability to lead and motivate teams
  • Proficient in Microsoft Office and problem-solving skills
  • Fluency in English

Responsibilities

  • Implement the global Quality Management Plan within the assigned scope
  • Conduct risk identification and assessment through quality control processes
  • Collaborate with stakeholders to enhance project delivery quality
  • Develop and monitor specific Quality and Risk Management programs
  • Advise teams on GCP compliance matters
  • Assist in managing non-compliance and planning corrective actions
  • Prepare reports on quality issues and improvement initiatives

Benefits

  • Opportunity to contribute to impactful quality improvement initiatives
  • Collaborative work environment with diverse stakeholders
  • Supportive role in regulatory audits and inspections
  • Professional development opportunities through engagement with management
  • Possibility to positively influence project outcomes and compliance standards
Full Job Description
Job Overview
This Clinical FSP role is assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to carry out and adopt the global Quality Plan according to the specific needs defined by the scope of the assignment, to assist the assigned business line staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines. Contribute to the development and be responsible for the implementation of specific quality improvement initiatives as agreed with the management and the relevant Head(s) of assigned business lines. Provide advice and support to relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.

Responsibilities
  • Adopt and implement the global Quality Management Plan within the scope of the assignment; this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness.;
  • Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.
  • Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.
  • Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
  • Work in close cooperation with teams to manage non-compliance, quality issues, assist in planning corrective/preventive actions, as applicable according to SOPs.;
  • Inform the assigned business line and Quality Assurance of quality issues according to SOPs.
  • Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
  • May provide assistance during audits and regulatory inspections to the teams to the extent agreed, as required by the applicable SOPs.
  • Prepare periodic reports to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.
  • Upon agreement the line manager: Perform any other reasonable tasks as required by the role.


Required knowledge, abilities and skills
  • Bachelor's Degree in health sector or related field or equivalent experience
  • Sound working knowledge of medical terminology, IQVIA standard operating procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.
  • Knowledge of National and International Regulations and Drug Development processes.
  • Knowledge Pharmaceutical industry operations.
  • Knowledge of IQVIA corporate standards and SOPs.
  • Good organizational, interpersonal and communication skills.
  • Good judgement and decision-making skills.
  • Strong influencing and negotiation skills.
  • Strong computer skills including Microsoft Office applications.
  • Excellent problem solving skills.
  • Ability to travel within the region/country.
  • Ability to lead and motivate a team.
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.
  • Fluent in English.


The potential base pay range for this role, when annualized, is $86,500.00 - $216,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

About IQVIA

Innovex offers superior and creative advice to corporations. In addition, they raised venture capital for our own affiliate companies, in addition to having assisted clients in fund-raising efforts, new venture outreaches, and financing. Their engineers and technical staff offer varied backgrounds in manufacturing, high tech, product design, quality control, safety, biomechanics, and robotics.

IQVIA Careers

Join the vibrant team at IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the healthcare industry. IQVIA is recognized for its commitment to innovation, leadership in healthcare, and a culture that celebrates diversity and inclusion.

Work You’ll Do

At IQVIA, we offer job opportunities that empower you to leverage your skills and drive healthcare forward. Become part of a team that thrives on innovation and the pursuit of operational excellence, helping to improve patient outcomes across the globe.

Transform Your Career

IQVIA is the place where you can transform the world of healthcare while advancing your career. With a variety of positions available, from research and development to business analytics, IQVIA is at the forefront of the industry. Our leadership is committed to fostering a culture of growth and professional development, making IQVIA a prime environment for both seasoned professionals and those seeking an internship to kickstart their career.

Innovative Work Environment

Join over 50,000 dedicated professionals in a dynamic environment where technology meets healthcare. At IQVIA, innovation isn’t just a buzzword; it's the backbone of how we solve complex challenges. With cutting-edge resources and a collaborative global team, your work at IQVIA directly contributes to advancements in life sciences.

Career Development and Benefits

IQVIA believes in nurturing its team members not just as employees but as individuals seeking to grow their careers. We support this with unmatched benefits, diversity training, and opportunities for leadership development. Our commitment to your career growth is matched by our dedication to providing a supportive and inclusive workplace.

Explore Job Opportunities

Whether you’re looking for a full-time position, part-time work, or a graduate internship, IQVIA offers a range of employment options to match your career ambitions. Our hiring process is designed to be transparent and engaging, helping you to understand where your skills can best be utilized within the company.

Networking and Professional Development

At IQVIA, networking and professional development are part of our DNA. Engage with industry leaders, participate in global conferences, and take advantage of our in-house training programs designed to enhance your skills and advance your career.

Stay Connected

Join Our Team Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players. Explore the diverse job opportunities at IQVIA and find where you can make an impact.

Keep Up to Date

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Job Alert Emails

Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at IQVIA. Embark on a journey of growth, innovation, and leadership at IQVIA. Shape your future in an environment that values diversity and fosters professional development. Join IQVIA today and transform healthcare through the power of information and technology.
Learn more about IQVIA
Size
82,000 employees
Market Cap
$37.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$279 million
Founded
2016
5 Year Trend
+15.3%
Revenue
$11.3 billion
NASDAQ
IQV
* Ladders Estimates

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