Senior Manager, Quality Standards and Compliance, GPSRM

Job Title: Senior Manager, Quality Standards and Compliance, GPSRM
Job Location: Cambridge, MA; Hybrid preferred; Open to remote (must work EST hours)
Job Duration: 5-6 Months(possibility of extension)
Payrate: $90 - $110/hr on w2

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Job Summary:

• The Senior Manager of Quality Standards and Compliance (QSC) will execute under direction, tasks supporting the development, implementation, and oversight of quality and compliance aspects within Global Patient Safety and Risk Management (GPSRM).

Key Responsibilities:

• Oversight and maintenance of the PSMF including provision of content to support PSMF requirements, as assigned.
• Act as a key point of contact between GVP Quality Assurance and GPSRM to ensure collaboration between the departments.
• Collaborate with GVP Quality Assurance to ensure the completion of annual pharmacovigilance risk assessments and development of the annual audit plan.
• Support PV audit activities on behalf of GPSRM in collaboration with GVP Quality Assurance.
• Support PV regulatory authority inspection activities on behalf of GPSRM in collaboration with GVP Quality Assurance.
• Facilitate the development, documentation and monitoring of quality events (e.g. deviations, corrective and preventive actions, effectiveness checks, etc.) related to PV activities to address compliance risks and ensure timely closure in collaboration with GVP Quality Assurance.
• Develop and report pharmacovigilance compliance metrics related to GPSRM activities to ensure oversight of operational performance and compliance with Key Performance Indicators (KPIs).
• Support the development and implementation of measures to manage compliance and oversight of external groups, vendors and affiliates that impact GPS deliverables.
• Oversee the late case process including investigations, root cause analysis and trending, correction development, and implementation.
• Author, review and/or approve content of controlled documents as needed and/or requested.
• Work proactively with cross-functional teams to advance quality and compliance activities relating to PV.

Education:

• Bachelor’s degree in life sciences or related field.

Experience:

• Minimum of 5 years in the pharmaceutical or life sciences industry with a focus on PV operations, quality, and compliance in a global environment.
• Knowledge of relevant global pharmacovigilance guidance and regulations (e.g. FDA, EMA, MHRA, Health Canada and International Conference on Harmonisation (ICH) guidelines, including Good Vigilance Practices (GVP) guidelines).
• Experience in rare diseases therapeutic area at a global level is an advantage.

Solid skills and experience in:

• Demonstrates expertise related to understanding the principles and application of quality and regulatory compliance.
• Demonstrates ability to effectively communicate and influence the outcomes of the decision-making process.
• Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to PV quality management.
• May conduct presentations on quality issues, initiatives and projects at cross functional meetings.

Special Skills:

• Ability to represent the functional department as an internal and external contact on pharmacovigilance quality and compliance deliverables relating to Global Patient Safety & Risk Management.
• Strong negotiation skills encouraging discussion and driving decisions to desired results.

Job Complexity:

• Support pharmacovigilance activities for the GPSRM department.
• Support cross-function relationships as well as those with business partners.

Supervision:

• Position will report directly to Director, QSC, Global Patient Safety & Risk Management.
• Individual is expected to work under direction of management and colleagues in GPSRM.
• This individual will communicate and collaborate with GPSRM subject matter experts to optimize departmental compliance and quality.

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