Pharmacovigilance QA Manager (Home Working Project) - #100179
Date: 04/19/2022 18:30 PM
City: Charlotte, North Carolina
Contract type: Full Time
Work schedule: Full Day
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
The Quality Manager provides leadership for quality activities and drives positive change and process improvement in Key Accounts. This role functions as an independent and objective entity and operates in a multifaceted function by working and supporting various operational teams. Serves as the central point of control for Audit Management, Deviation and CAPA Management, Document Control, and other Quality Management System activities related to Key Accounts. Develops, manages, and executes quality management processes to ensure quality standards are maintained and compliant with regulatory requirements.
- Perform day-to-day management of quality management activities to ensure high quality services and compliance with applicable current Good Practices (cGXPs), including GMPs, GCPs and GVPs.
- Maintain awareness of, and ensuring compliance with, the legal requirements and professional guidelines associated with the provision of Pharmacovigilance (PV) and Clinical Pharmacovigilance (CPV) on behalf of the pharmaceutical industry.
- Generate weekly monthly, and quarterly reporting to identify trends pertaining to the performance of the quality management system.
- Identify potential quality failures and establish appropriate corrective actions including coordination of their implementation.
- Oversee Standard Operating Procedure (SOP) and other controlled document development and maintenance process and participate in procedure development as appropriate
- Serve as Subject Matter Expert (SME) for Operational Managers and Client Services in investigating and Deviations, Quality Events, identifying CAPAs.
- Lead client audits and regulatory inspections processes by engaging with auditor/inspector in the coordination and finalization of agenda, document provision; ensuring internal logistics and SMEs are in place; host and facilitate the audit/inspection; coordination and management of audit CAPA responses; and finally ensuring audit information is maintained and stored in eQMS.
- Support internal audit activities, throughput coordination and management of CAPA responses, which requires close collaboration with management.
- Participate in relevant client operational meetings (i.e., standard meetings, Business Review and Ad Hoc meetings requiring QA representation)
- Liaising and communicating with all applicable internal and external stakeholders on all aspects of Quality responsibilities in a professional and business focused manner to ensure good relations between the Quality, Client, and other internal team members. Other duties as assigned.
- Proficient computer knowledge and computer keyboarding skills including intermediate proficiency with Microsoft Office Suite (Outlook, Word, Excel)
- Previous pharmacovigilance quality experience
- Excellent attention to detail
- Excellent organization and prioritization skills; with strong attention to detail
- Able to work independently and collaboratively.
- Able to occasionally work extended and/or flexible schedule to meet client requirements
- Required: 5 years of Quality operations experience required within the pharmaceutical, biotech and/or medical device industries
- Required: 2 years’ experience hosting, leading and/or attending audits as a Quality representative
- Required: Quality Management System experience including hands on experience with 21 CFR Part 820/ICH 10
- Required: Drug safety experience
- Preferred: Experience working with safety databases
- Preferred: Previous experience as a people manager
- University/Bachelor’s degree and/or or appropriate relevant work experience
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All candidates must be legally eligible to work in the United States. Employees can work remotely in this role, from the US.
This position is an 8 to 12 month project role.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
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