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Detailed Description

The MIPV Quality Manager, Americas will lead and provide direction for activities and functional capabilities within the Americas Quality department, including oversight and hands-on execution of essential aspects of operational quality for pharmaceutical and medical device industry regulated services. Serves as the central point of control for Audit Management, Deviation and CAPA Management, Document Control and other Quality Management System Activities. Maintains distinctive quality and commitment as the operating philosophy in carrying out all processes while continually seeking out ways to enhance customer service experience, both internally and externally. Work collaboratively within all aspects of the company to harmonize and standardize current and future processes.

Staff Management

• Manage, develop, and support Quality team members to ensure that they have the necessary skills to drive an effective Quality Management System.
• Lead, provide oversight and direction to Quality Department to maintain standards of quality and productivity and adherence to policies and procedures.
• Make decisions consistently with company guidelines and polices.
• Foster teamwork and collaboration; resolve conflict.
• Monitor and provide ongoing performance feedback and conduct annual performance and compensation reviews.
• Participate in staffing responsibilities such as hiring, schedules, performance/disciplinary, training, separations.
• Review workload and task allocation on an ongoing basis to ensure effective utilization of all members of the team.
• Plan comprehensively to ensure continuity of services with staff changes within a team e.g., maternity leave.
• Communicate needs of the department and provide solutions to management.
• Mentor, train and develop staff for continued professional growth.
• Other duties as assigned.

Quality Operations

• Implement and maintain the Quality Management System and processes to ensure high quality services and compliance with applicable current Good Practices (cGXPs), including GMPs, GCPs and GVPs.
• Identify opportunities to continuously improve processes and efficiencies within the Quality Department.
• Be knowledgeable and comply with Propharma's SOPs as well as have an awareness of client-specific processes and documentation.
• Assist the Director of Global PV Quality in maintaining awareness of, and ensuring compliance with, the legal requirements and professional guidelines associated with the provision of Medical Information (MI), Pharmacovigilance (PV) and Clinical Pharmacovigilance (CPV) on behalf of the pharmaceutical industry.
• Support the monitoring and assessment for quality of the MI, PV and CPV services provided by Propharma.
• 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.
• Manage deviation and CAPA procedures.
• Assist Operational Managers and Client Services in investigating complaints and deviations, identifying CAPAs and communicating these to the internal and external stakeholders.
• Support the execution of internal audits, including documenting and evaluating findings, writing audit report, and collaborating with management for corrective and preventative action.
• Coordinate and participate in client and regulatory body audits by representing Quality in audits and regulatory inspections, creating, and maintaining audit files, and coordinating audit responses as appropriate.
• Collaborate with Quality Leadership at all Propharma locations to provide quality related response to Request for Proposal and other client requests.
• Take responsibility for the delivery of regular and ad hoc client-specific quality reports for specified clients.
• Contribute to best practice discussions related to Quality Management System with global colleagues.
• Other duties as assigned.

Business Support and Development

• Produce management reports on a regulatory or ad-hoc basis, including updating on any quality-related issues or successes related to Propharma processes or personnel.
• Participate in relevant client operational meetings as directed by Management.
• Identify any issues that could potentially impact services and escalate any areas of concern within the business to senior management, with potential corrective actions.
• Identify potential business development opportunities and raise these with senior management.
• Support Client Services to respond to all client communications in a positive, professional, and timely manner.
• Support Client Services in retrospectively reviewing past performance for clients and identifying trends or patterns to facilitate further improvements for the client.
• Strive to improve efficiency within the teams by assessing existing processes and suggesting improvements where possible.
• In agreement with the Director of Global PV Quality, take responsibility for other tasks to support the needs of the business.

Necessary Skills and Abilities

• Comfortable in a matrix management organization.
• Proficient computer knowledge and computer keyboarding skills, including Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)
• Experience working with databases.
• Exceptional organization, prioritization, project management and delegation skills; able to multitask.
• Excellent verbal, written and interpersonal communication skills with the ability to establish strong professional relationships with clients, regulatory agency representatives and internal staff.
• Able to communicate quality issues to non-quality staff in a clear and concise manner.
• Excellent attention to detail and commitment to quality.
• Exceptional customer service skills within quality, and with clients.
• Able to build positive collaborations with other departments and open to change.
• Willing to train internally or externally the fundamentals of working within a regulated Quality System.
• Strong decision-making skills.
• Strong problem-solving skills.
• Able to project and maintain professionalism in handling difficult situations and in times of stress.
• Flexibility to adapt and meet fluctuating business priorities.
• Must be willing to fly within the US and internationally.

Educational

• Required: Bachelor's degree or equivalent.

Requirements

• Preferred: Quality certification in a job-related field.

Experience Requirements

• Recommended to have at least 3 years of managing direct reports or equivalent responsibilities.
• Required: 5 years of Quality operations experience and/or healthcare regulatory experience within the pharmaceutical or medical device industry.
• Required: Experience hosting and attending audits as a Quality representative.
• Preferred: Working knowledge of quality audit practices in pharmaceutical and medical device relating to MI, PV, and CPV.