Senior Manager PV Compliance Audit - New Jersey, NJ | Biospace
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Senior Manager PV Compliance Audit

Omega Management Group

New Jersey, NJ
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Key Points:
•   The experienced Pharmacovigilance/Drug Safety Senior Manager would be responsible for leading and conducting complex process/system audits, affiliate/local operating company audits, and Contract/License Service Providers in areas such as drug safety, risk management, REMS.
•   Must be able to work diligently both within a global team setting and individual in the US New Jersey headquarters.
•   Audits will involve global travel, and process/system audits include such areas as aggregate reporting, signal detection, case processing, and Market Research.
•   There will also be overlap in the PV audit program with GCP (e.g. Investigator brochure, IIT processes), GMP (Product recall process, Medical Affairs) and CSV (ARISg database review).
•   On average, the Senior Manager will be required to conduct approximately 6-8 audits each year, in addition to involvement in other compliance initiatives.

Summary / Scope:  
•   Plans, conducts and follows up on GxP audits of assigned entities to assess compliance with regulatory and internal requirements; identify compliance risks and drive concurrence regarding their severity
•   Contribute to planning and operational analyses for discipline
•   Scope includes internal and external audits of global sites/affiliates, processes and vendors

Core Responsibilities:
•   Serves as a subject matter expert within the unit.
•   As the lead, plans and executes highest risk, most complex audits/compliance projects under minimal supervision.  As a team member, independently executes high risk elements of the audit/compliance projects.  
•   Must be able to multi-task required work for the role, in addition to ad-hoc / department projects.
•   Supervises and provides guidance to unit colleagues beyond just a team/audit/project setting.
•   May mentor colleagues and be viewed as a leader/mentor.
•   Demonstrates the ability to multi-task responsibilities.
•   Assists in the development of the annual audit plan (where applicable).
•   Assists in the development of the department training plan; trains and develops junior staff.
•   May provide guidance / recommendations to clients re business practice or compliance issues.
•   Provides input to audit/inspection criteria, programs, and plans.  
•   Maintain audit database for observations and audit CAPA.
•   Contribute to the development and implementation of Standard Operating Procedures


•   Minimum of Bachelors Degree
•   Ten (10)  plus years of relevant GxP pharmaceutical/biotechnology industry experience, including minimum four (4) to six (6) years of compliance related or auditing experience (or equivalent)
Key Requirements :
•   Advanced subject matter expert in the required technical knowledge and expertise.
•   Ability to analyze emerging compliance issues and recommend strategies to manage compliance risks.
•   Travel: Position requires about 25% domestic and international travel.