Senior Clinical Quality Assurance Manager

WEP Clinical; United States; On-site; USD 100,000 - 130,000; Full time

Job summary

Join a mission-driven organization as a Senior Clinical Quality Assurance Manager, where you will oversee compliance with quality standards in clinical trials. Your leadership will ensure adherence to regulatory requirements while driving impactful solutions that improve patient outcomes. Collaborate with global teams to enhance clinical services and ensure ethical conduct in research. Enjoy competitive benefits and a supportive work environment dedicated to professional growth.

Benefits

Medical, dental, and vision insurance

FSA, HSA

Voluntary short-term and long-term disability insurance

Voluntary life insurance

401K safe harbor plan and company match

Paid vacation, holiday, and sick time

Paid maternity & paternity leave

Qualifications

• 7+ years of experience in clinical research focusing on quality assurance.
• In-depth knowledge of clinical trial methodologies and GCP guidelines.

Responsibilities

• Develop and maintain a quality assurance framework for clinical services.
• Conduct audits and inspections to assess compliance and implement corrective actions.
• Manage quality records and processes including deviations and change controls.

Skills

Decisive

Adaptable

Detail Oriented

Analytical

Interpersonal Skills

Education

Bachelor’s degree or higher

Job description

Senior Clinical Quality Assurance Manager

Senior Clinical Quality Assurance Manager

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

Role Objectives:

The Senior Clinical Quality Assurance Manager at WEP Clinical oversees the maintenance and compliance of the Quality Management System, ensuring adherence to quality principles and Good Clinical Practice (GCP) regulatory requirements. This role supports key stakeholders across global clinical operations, including clinical trial management and the patient-enabling solutions group, which encompasses home health solutions, virtual clinical trials, patient concierge services, and patient recruitment. Additionally, the Senior Clinical Quality Assurance Manager is responsible for developing, implementing, and maintaining quality assurance standards and processes to uphold the safety, efficacy, and ethical conduct of clinical trials in compliance with GCP.

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

Role Objectives:

The Senior Clinical Quality Assurance Manager at WEP Clinical oversees the maintenance and compliance of the Quality Management System, ensuring adherence to quality principles and Good Clinical Practice (GCP) regulatory requirements. This role supports key stakeholders across global clinical operations, including clinical trial management and the patient-enabling solutions group, which encompasses home health solutions, virtual clinical trials, patient concierge services, and patient recruitment. Additionally, the Senior Clinical Quality Assurance Manager is responsible for developing, implementing, and maintaining quality assurance standards and processes to uphold the safety, efficacy, and ethical conduct of clinical trials in compliance with GCP.

The Ideal Candidate:

• Decisive and strategic leader
• Adaptable and solution-oriented
• Detail Oriented and analytical
• Strong interpersonal skills

What You'll Do:

• Develop, implement, and maintain a comprehensive quality assurance framework for clinical services, ensuring compliance with GCP, FDA, EMA, and internal standards
• Manage quality records and processes, including deviations, change controls, CAPAs, complaints, and other quality incidents
• Conduct risk assessments to identify and mitigate potential quality risks in nursing and clinical services
• Perform audits and inspections to assess compliance, identify non-conformances, and implement corrective actions
• Host external client and regulatory inspections, coordinating audits and responses
• Monitor, develop, and deliver training on quality assurance principles, regulatory requirements, and SOPs
• Oversee external vendors to ensure compliance with quality standards and regulatory requirements
• Ensure compliance with regulatory requirements, including GCP, data privacy laws (e.g., GDPR), and local regulations
• Identify and implement process improvements to enhance the quality and efficiency of clinical services and home health solutions
• Serve as the key quality contact for projects, supporting setup and liaising with clients as needed

What You'll Need:

• Bachelor’s degree or higher, preferably in pharmaceutical sciences, life sciences, or nursing
• 7+ years of experience in clinical research with a focus on quality assurance and/or clinical services
• In-depth knowledge of clinical trial methodologies, regulatory requirements, and GCP guidelines
• Experience with decentralized clinical trials and remote patient monitoring is a plus
• Demonstrated expertise in developing and implementing quality assurance systems, change management, and processes

What We Offer:

Medical, dental, and vision insurance, FSA, HSA

Voluntary short-term and long-term disability insurance

Voluntary life insurance

401K safe harbor plan and company match

Paid vacation, holiday, and sick time

Paid maternity & paternity leave

What Sets Us Apart:

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

We're Committed to Our Team:

WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.

We're Committed to DEI:

At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.

Our services include:

Access Programs

Clinical Trial Services

Patient Site Solutions

Clinical Trial Supply

Market Access and Commercialization

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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