Job Description

This is a 3-4 month contract position in Anaheim/Corona, CA. A Quality Manager will lead and provide direction for activities and functional capabilities for the Quality Department.  Provide oversight and hands-on execution of essential aspects of operational quality for pharmaceutical and medical device industry regulated services. Serve as the central point of control for SOPs and other Quality Management System controlled documents. Maintain distinctive quality and commitment as the operating philosophy in carrying out all processes. Continually seek out ways to enhance customer service experience both internally and externally.

ESSENTIAL FUNCTIONS INCLUDE: Staff Management 1.    Lead, provide oversight and direction to Quality Department to maintain standards of quality and productivity and adherence to policies and procedures 2.    Demonstrate leadership, coach, mentor, motivate and develop staff 3.    Make decisions consistent with company guidelines and policies 4.    Foster teamwork and collaboration; resolve conflict 5.    Monitor and provide staff ongoing performance feedback and conduct annual performance and compensation reviews 6.    Participate in staffing responsibilities: hiring, schedules, performance/disciplinary, training, separations 7.    Review workload and task allocation on an ongoing basis to ensure effective utilization of all members of the team. 8.    Plan comprehensively to ensure continuity of services with staff changes within a team e.g. maternity leave 9.    Communicate needs of the department and provide solutions to management 10.    Other duties as assigned Quality Operations 1.    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. 2.    Be knowledgeable and comply with SOPs as well as have an awareness of client-specific processes which may be documented in Working Practices/Client Instructions/other documentation. 3.    Assist the Director of Global 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 Services (CL) on behalf of the Pharmaceutical Industry. 4.    Support the monitoring and assessment for quality of the MI, PV and CL services provided by ProPharma Group. 5.    Identify potential quality failures and establish appropriate corrective actions including coordination of their implementation. 6.    Oversee Standard Operating Procedure (SOP) and other controlled document development and maintenance process and participate in procedure development as appropriate 7.    Develop and conduct internal annual cGXP training 8.    Manage deviation and CAPA procedures 9.    Assist Operational Managers and Client Services in investigating complaints and deviations, identifying CAPAs and communicating these to the internal and external stakeholders. 10.    Support the execution of internal audits a.    Document and evaluate findings b.    Write audit report c.    Collaborate with management for corrective and preventive action 11.    Coordinate and participate in client and regulatory body audits a.    Represent Quality in audits and inspections b.    Create and maintain audit files c.    Coordinate audit response as appropriate 12.    Coordinate vendor qualification procedures 13.    Collaborate with Quality leadership at all ProPharma Group locations to provide quality related response to Request for Proposal and other client requests 14.    Take responsibility for the delivery of regular and ad hoc client-specific quality reports for specified clients 15.    Contribute to best practice discussions related to the Quality Management System with global colleagues (this may involve visiting other ProPharma Group sites globally) 16.    Other duties as assigned Business Support and Development 1.    Produce management reports on a regular basis, including updating on any quality-related issues or successes related to ProPharma Group processes or personnel. 2.    Participate in relevant client operational meetings as directed by Management. 3.    Identify any issues that could potentially impact services, and escalate any areas of concern within the business to Senior management, with potential corrective actions. 4.    Identify potential business development opportunities and raise these with Senior management. 5.    Support Client Services in forging excellent working relationships with clients. 6.    Support Client Services to respond to all client communications in a positive, professional and timely manner. 7.    Support Client Services in retrospectively reviewing past performance for clients and identifying trends or patterns to facilitate further improvements for the client. 8.    Proactively identify improvement opportunities to support the continuing development of ProPharma Group as a leading provider of outsourced global Medical Information solutions. 9.    Strive to improve efficiency within the teams by assessing existing processes and suggesting improvements where possible. 10.    Consider decisions in a business focused manner ensuring that they are as cost effective and efficient as possible. 11.    In agreement with the Director of Global Quality, take responsibility for other tasks to support the needs of the business.  

Qualifications

1.    Bachelor’s degree or equivalent 2.    Preferred: Quality certification in a job-related field 3.    Required: 5 years of Quality operations experience within a drug or cosmetic background 4.    Required: Experience attending audits as a Quality representative 5.    Preferred: Working knowledge of quality audit practices in pharmaceutical and medical device relating to MI, PV, and CL.

Necessary Skills and Abilities: 1.    Proficient computer knowledge and computer keyboarding skills 2.     Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint) 3.    Experience working with databases 4.    Exceptional organization, prioritization, project management and delegation skills; able to multitask 5.    Excellent verbal, written and interpersonal communication skills with the ability to establish strong professional relationships with clients, regulatory agency representatives and internal staff 6.    Able to communicate quality issues to non-quality staff in a clear and concise manner 7.    Excellent attention to detail and focus on quality 8.    Exceptional customer service skills 9.    Strong decision making skills 10.    Strong problem-solving skills 11.    Able to project and maintain professionalism in handling difficult situations and in times of stress 12.    Flexibility to adapt and meet fluctuating business priorities 13.    Must be willing to fly within the US and Internationally  

Additional Information

Candidates must be legally eligible to work in the United States. 

We are an equal opportunity employer. M/F/D/V

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.