Job description
Job Title: Associate Clinical Quality Operations Manager, Oncology III
Job Title:Job Location: Lima, Peru
Job Location:Job Location Type: Remote
Job Location Type:Job Contract Type: Full-time
Job Contract Type:Job Seniority Level:
Job Seniority Level:Job Description
The Associate Clinical Quality Operations Manager (ACQOM) plays a key role in ensuring our company receives consistent, accurate, and high-quality clinical trial data worldwide. Working closely with the Clinical Quality Operations Lead (CQOL) and Head of CQO, the ACQOM supports operational quality management, risk management, inspection readiness, supplier oversight, and continuous quality improvement within assigned therapeutic areas.
Key Responsibilities
Key ResponsibilitiesClinical Trial Quality Support
Clinical Trial Quality Support- Support Clinical Trial Teams embedding Quality by Design (QbD) principles throughout clinical development programs.
Support Clinical Trial Teams embedding Quality by Design (QbD) principles throughout clinical development programs.
Quality by Design (QbD)- Conduct quality control activities to identify emerging study risks, process gaps, and quality issues.
Conduct quality control activities to identify emerging study risks, process gaps, and quality issues.
- Review quality documentation and trial quality folders for completeness and accuracy.
Review quality documentation and trial quality folders for completeness and accuracy.
- Assist with mergers, acquisitions, and integration activities to ensure knowledge transfer, risk mitigation, and inspection readiness.
Assist with mergers, acquisitions, and integration activities to ensure knowledge transfer, risk mitigation, and inspection readiness.
Risk Management
Risk Management- Develop expertise in risk management tools and processes
Develop expertise in risk management tools and processes
- Review critical data and processes throughout the clinical trial lifecycle to ensure risks are identified, monitored, and mitigated.
Review critical data and processes throughout the clinical trial lifecycle to ensure risks are identified, monitored, and mitigated.
Regulatory Inspection Readiness
Regulatory Inspection Readiness- Support sponsor and investigator-site inspections and help maintain ongoing inspection readiness.
Support sponsor and investigator-site inspections and help maintain ongoing inspection readiness.
- Participate in Inspection Support Teams (ISTs).
Participate in Inspection Support Teams (ISTs).
- Manage and track Corrective and Preventive Actions and regulatory commitments through completion.
Manage and track Corrective and Preventive Actions and regulatory commitments through completion.
- Perform quality reviews of inspection documentation repositories and support inspection response development.
Perform quality reviews of inspection documentation repositories and support inspection response development.
- Analyze inspection outcomes for trends and lessons learned.
Analyze inspection outcomes for trends and lessons learned.
Quality Assurance Audits
Quality Assurance Audits- Assist with audit preparation, facilitation, root cause analysis, response development, and CAPA management.
Assist with audit preparation, facilitation, root cause analysis, response development, and CAPA management.
- Provide project management support for audit-related activities and CAPA implementation.
Provide project management support for audit-related activities and CAPA implementation.
Third-Party Supplier Oversight
Third-Party Supplier Oversight- Support oversight of clinical research vendors and suppliers to ensure compliance and quality performance.
Support oversight of clinical research vendors and suppliers to ensure compliance and quality performance.
- Assist with quality agreements, audits, inspections, performance monitoring, issue resolution, risk management, and CAPA development.
Assist with quality agreements, audits, inspections, performance monitoring, issue resolution, risk management, and CAPA development.
CQO Infrastructure and Continuous Improvement
CQO Infrastructure and Continuous Improvement- Contribute to process innovation and improvement initiatives.
Contribute to process innovation and improvement initiatives.
- Develop advanced knowledge of global Good Clinical Practice (GCP) requirements, including ICH, FDA regulations, and EMA Clinical Trial Regulations.
Develop advanced knowledge of global Good Clinical Practice (GCP) requirements, including ICH, FDA regulations, and EMA Clinical Trial Regulations.
ICH, FDA regulations, and EMA Clinical Trial RegulationsEducation
Education- Bachelor's or Master's degree (or equivalent) in a relevant healthcare, life sciences, or related field.
Bachelor's or Master's degree (or equivalent) in a relevant healthcare, life sciences, or related field.
- Additional formal education or certification in Quality Management or Business Management is preferred.
Additional formal education or certification in Quality Management or Business Management is preferred.
Quality ManagementBusiness ManagementExperience
Experience- Minimum 4 years of experience in the pharmaceutical industry and/or clinical research.
Minimum 4 years of experience in the pharmaceutical industry and/or clinical research.
4 years of experience- Knowledge of quality management and risk management methodologies is desirable.
Knowledge of quality management and risk management methodologies is desirable.
quality managementrisk management methodologies- Understanding of clinical development programs and clinical trial processes.
Understanding of clinical development programs and clinical trial processes.
clinical development programsclinical trial processes- Experience with Quality Management Systems (QMS).
Experience with Quality Management Systems (QMS).
Quality Management Systems (QMS)- Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and global regulatory health authority requirements.
Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and global regulatory health authority requirements.
Good Clinical Practice (GCP), ICH guidelines, and global regulatory health authority requirements- Prior experience conducting root cause analysis and managing Corrective and Preventive Actions (CAPAs).
Prior experience conducting root cause analysis and managing Corrective and Preventive Actions (CAPAs).
root cause analysisCorrective and Preventive Actions (CAPAs)Key Skills & Competencies
Key Skills & CompetenciesCommunication & Collaboration
Communication & Collaboration- Excellent verbal and written communication skills in a global environment.
Excellent verbal and written communication skills in a global environment.
- Strong teamwork and leadership abilities.
Strong teamwork and leadership abilities.
- Skilled in conflict resolution and handling sensitive matters with discretion.
Skilled in conflict resolution and handling sensitive matters with discretion.
- Ability to influence stakeholders and collaborate effectively across all organizational levels.
Ability to influence stakeholders and collaborate effectively across all organizational levels.
Leadership & Project Management
Leadership & Project Management- Strong project management and organizational skills.
Strong project management and organizational skills.
- Ability to lead cross-functional teams within and outside the organization.
Ability to lead cross-functional teams within and outside the organization.
- Capable of driving initiatives and achieving results through collaboration and influence.
Capable of driving initiatives and achieving results through collaboration and influence.
Analytical & Strategic Thinking
Analytical & Strategic Thinking- Ability to analyze, interpret, and resolve complex issues.
Ability to analyze, interpret, and resolve complex issues.
- Strong strategic thinking, creativity, and innovation skills.
Strong strategic thinking, creativity, and innovation skills.
- Ability to identify trends, risks, and key findings from audits and inspections.
Ability to identify trends, risks, and key findings from audits and inspections.
Inspection & Compliance Management
Inspection & Compliance Management- Ability to act with urgency and effectiveness during global regulatory inspections.
Ability to act with urgency and effectiveness during global regulatory inspections.
- Skilled in summarizing audit and inspection findings and translating them into actionable lessons learned.
Skilled in summarizing audit and inspection findings and translating them into actionable lessons learned.
- Experience supporting compliance, quality oversight, and continuous improvement initiatives.
Experience supporting compliance, quality oversight, and continuous improvement initiatives.
Required Skills:
Required Skills:Preferred Skills:
Preferred Skills:Current Employees apply HERE
HERECurrent Contingent Workers apply HERE
HERESearch Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Search Firm Representatives Please Read CarefullyEmployee Status:
Employee Status:Relocation:
Relocation:VISA Sponsorship:
VISA Sponsorship:Travel Requirements:
Travel Requirements:Travel Requirements:Flexible Work Arrangements:
Flexible Work Arrangements:Shift:
Shift:Valid Driving License:
Valid Driving License:Hazardous Material(s):
Hazardous Material(s):Job Posting End Date:
Job Posting End Date:*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.Requisition ID:R410791
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