CAREER PORTAL

Sr. Manager

Senior Manager, Quality Standards and Compliance, Global Patient Safety & Risk Management
Cambridge, MA:  Hybrid preferred but will consider remote
Contract: Ideally 9/16 (open to 9/3 or 9/30) through March
Pay Rate:  $105 - $110 per hour (depending on experience)


***This role requires quality management system experience (Veeva) along with a PV Operations background (5 + years), deviation/investigation writing, CAPA, metrics/KPI’s and compliance

Nice-to-Have: Regulatory background (PV + Regulatory Ops)

Skills/Tools: Excel (formulas/pivot tables), Power BI, Smartsheet, strong communication

Other Qualifications: 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

Education: Bachelor’s degree in life sciences or related field.


Overview:  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

      
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.
 

Estimated Min Rate: $105.00
Estimated Max Rate: $110.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.