Responsibilities:

• Work with Quality team members to develop, implement, and maintain a phase appropriate Quality Management System (QMS) through the creation, review and approval of documentation including policies and standard operating procedures (SOPs).
• Shared ownership in the development, implementation, and maintenance of Quality System, including facilitating process improvement activities to the product and project teams for continuous improvement.
• Support the development and oversight of robust quality systems, including both implementation and operation at site level.
• Proactive monitoring of compliance with Quality System reviews, Corrective and Preventive Actions, training, internal auditing, and supplier management. Assist in the maintenance of the corrective/preventive action program, inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for timely completion and periodic reports and metrics.
• Document and report quality and compliance issues to management according to required timelines.
• Facilitate the use of a risk-based approach for decision-making within the QMS. Properly escalate high quality risks per procedure.
• Support quality management review and perform assessments including periodic internal compliance audits to ensure adherence to Quality Standards.
• Participates in the evaluation of quality events, incidents and possible complaints or compliments and the follow-up events. Assist in preparation and review of corrective action plans associated with customer audits. Plan, schedule, conduct, report and close assigned audit activities in any of the countries involved with services to assess compliance with applicable regulations/guidelines, customer requirements, SOPs and project specific guidelines/instructions.
• Serve as key escalation and QA contact globally with focus on assigned/regional office locations. Provide guidance and direction to key operational and delivery stakeholders in matters of compliance and best practice.
• Review systems and analyze data (paper or electronic) to identify specific data integrity and data consistency issues with oversight.
• Contribute to the site inspection preparation, management and response process.
• Represent Quality Assurance on customer and project teams and in meetings.
• Work with the management team to integrate quality risk management concepts and philosophies into the overall Quality System.
• Monitor and report key performance indicators as appropriate.
• Assist in implementing new technologies to improve the compliance and efficiency of QS operations.
• Host customer audits, mock regulatory inspections, and regulatory facility inspections.
• Aligns QA resources towards specific functional efforts to improve operational effectiveness and consistency, efficiency, and quality of delivery. Able to combine strategy with conventional and unconventional thinking to form innovative, yet compliant solutions.
• Examine current landscape to determine where new or updated processes may provide value added benefit, risk reduction, and efficiencies. Creates the Quality Manual, with a regular review cycle.
• Assists in definition, execution, and reporting of Quality Assurance objectives and assigned initiatives.
• Conduct ongoing training and support for new and existing staff on the Quality Manual and other key areas including Corporate SOPs, GCP, 21 CFR Part 11, validation, and process improvement/problem solving.
• Perform Vendor Evaluation / Vendor audits as required.
• Liaise with customers and suppliers where necessary (where impacting/affected by quality issues).
• Enhance and maintain a working knowledge of relevant GXP regulations. Keep up to date with all related quality legislation and compliance issues.
• Provides guidance and oversight to direct report(s) including the management of workload, special projects, performance management, salary review, and career development.

Requirements:

• Significant experience in hosting and/or conducting audits of computerized systems with clinical trial relevance. Intermediate familiarity with computerized systems validation methodologies.  Practical experience in hosting customer audits and/or regulatory inspections
• Practical experience in conducting either internal process, project, site or vendor audits.
• Practical experience applying proactive Quality approaches for clinical trials.
• Previous experience in quality risk management.
• Comprehensive understanding of quality management systems initiatives and standards, including experience in writing policies and procedures. Ability to promote Quality culture throughout the business.
• Direct experience reviewing and/or authoring standard operating procedures.
• Established client facing communication skills – ability to manage situations, negotiate conflicts, and influence others to achieve objectives
• Strong follow-up and organizational skills.
• Strong problem solving/process improvement skills with ability to be part of and own solutions.
• Drive to seek solutions with intent and priority through a balance of creativity and restraint.
• Expected and empowered to make decisions without direct supervision. Ability to work well independently and within a team.
• BS or equivalent in life science or related field
• 8+ years industry experience in Quality Assurance for a pharma, biotech, and/ or contract/academic research organization; Primary focus in GCP but familiarity with GLP and GMP expected
• Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint).
• Experience with Oracle Argus preferred
• This position will require international travel