Quality Manager
3 weeks ago
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Quality Manager provides leadership for quality activities and drives positive change and process improvement in the assigned region. This role functions as an independent and objective entity and operates in a multifaceted function by working and supporting various operational teams. The Quality Manager performs quality activities as outlined in ProPharma Group’s Quality Policy and procedures. Serves as the central/regional point of control for Client Audit and Inspection Management, Deviation and CAPA Management, Document Control, and other Quality Management System activities. Develops, manages, and executes quality management processes to ensure quality standards are maintained and compliant with regulatory requirements
Essential Functions:
Personnel Management:
Provides direction, guidance, support, and ongoing performance feedback to direct reports.nMake decisions consistent with company guidelines and policies.nFosters an environment of teamwork and collaboration, across global regions.nConducts annual performance and compensation reviews.nParticipate in staffing responsibilities such as hiring, schedules, performance/disciplinary, training, separations.nReview workload on an ongoing basis to ensure effective resource allocation and utilization.
General
Work collaboratively within all aspects of the company to harmonize and standardize current and future processes.nManage, develop, and support Quality team members to ensure that they have the necessary skills to drive an effective Quality Management System.nMentor, train and develop staff for continued professional growth.nImplement 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.nMaintain awareness of, and ensure compliance with, the regulatory requirements and professional guidelines associated with the provision of Medical Information (MI), Pharmacovigilance (PV) and Clinical Pharmacovigilance (CPV) on behalf of the pharmaceutical industry.nIdentify potential quality failures and establish appropriate corrective actions including coordination of their implementation.nOversee Standard Operating Procedure (SOP) and other controlled document development and maintenance process and participate in procedure development as appropriatenServe as Subject Matter Expert (SME) for Operational Managers and Client Services in investigating and deviations, Quality Events, identifying CAPAs and communicating these to the internal and external stakeholders.nSupport internal audit activities, throughput coordination and management of CAPA responses, which requires close collaboration with management.nLead or support 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.nOversee coordination of client Questionnaire responses.nParticipate in relevant client operational meetings (i.e., standard meetings, Business Review and Ad Hoc meetings requiring QA representation).nLiaising and communicating with all applicable internal and external stakeholders on all aspects of the Quality team’s responsibilities in a professional and business focused manner to ensure good relations between the Quality Department and the rest of ProPharma Group globally, and its clients.nPerform other duties as required
Experience required
Must be educated to a BSc or higher within a life-sciences or engineering disciplinenMust have at least 5 years or more in Quality Operations within the Life-sciences sectornMust have at least 2 years direct experience hosting and attending audits as the Quality representativenCan demonstrate at least 3 years experience in a people management positionnProven experience managing and improving a QMS is vitalnSound knowledge of Pharmacovigilance and Medical Information would be highly desirablenFluent in EnglishnExcellent communication and Stakeholder management skillsnDriven, open to change and results orientated
Additional Information
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.n***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails***
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