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ExecuPharm FSP- Clinical Quality Operations Manager

Parexel International Corporation

USA - Any Region - Home Based

Job Title: ExecuPharm FSP- Clinical Quality Operations Manager (CQOM)

Position Purpose:

The CQOM, in collaboration with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations (CQO), is responsible for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities.

The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into Client sponsored trials, ensure adequate vendor oversight and address any quality issues as needed.

The CQOM will be responsible for the development of Quality Plans to implement `Quality by Design` within clinical Development Programs, using a risk-based approach.

The CQOM will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.

Organizational Relationships:

• Reports to ExecuPharm (EP) assigned Line Manager with day-to-day project work direction from the Client

Primary Duties:

Operational Quality Management

Inspection Preparation and Management

CAPA Management Support

Other activities:

• Provide input into GCP Quality and Compliance Council regarding the Quality Management Systems (QMS), Risk Assessment Categorization Tool (RACT), Quality Plans and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.

• Assess and provide input to strengthen company programs/strategies (e.g. QCV, HQ QCP) with an aim to increase Inspection Readiness.

• Lead, drive, facilitate and/or support remediation, prevention activities as process improvement and training, as needed.

General:

• Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.

• Adhere to EP and Client SOPs and processes.QualificationsSkills and Education:

• Bachelor’s/ Master’s Degree or equivalent in relevant health care area. Further formal education in quality management or business management is desirable.

• Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.

• Profound knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required.

• Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.

• Experience with delivering effective CAPA management solutions.

• Experience with risk management tools and processes within the clinical quality framework.

• Superior oral and written communication skills in an international environment.

• Ability to manage and develop others, including formal performance management when required.

• Excellent project management and organizational skills.

• Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.

• Ability to lead cross-functional teams of business professionals within and outside Client

• Able to act urgently for worldwide health authority inspection matters.

• Ability to analyze, interpret and solve complex problems.

• Ability to think strategically and objectively and with creativity and innovation.

• Ability to proficiently interact with all levels of specialists & management and exert influence to achieve results.

• Ability to identify and summarize the key issues from audits and inspections and to develop and deliver lessons learned.

• Extent of Travel 20%EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job posted: 2021-03-26

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