• Oversee the quality team members, which include quality specialists (document control, post-market surveillance, auditing, supplier quality management)
• Manage the Quality Management System (QMS) and oversee the Quality operations 
• Ensure compliance with quality system regulations, developing and monitoring quality metrics, preparing Quality reports, and participating in the planning and implementation of quality procedures
• Work with the R&D and Operations teams on quality control and quality assurance procedures, technical troubleshooting and improvement procedures, and training and education programs
• Establish and maintain systems, policies, and procedures to ensure product quality and compliance with applicable regulatory requirements (e.g., QSR, ISO, CLIA, CAP, and other applicable state regulations etc.) and company policies and procedures
• Support IVD development activities and provide direction on product development activities (including Design Controls, Risk Management, etc.) 
• Ensure continued compliance with internal procedures and applicable regulations
• Capture, trend, and analyze quality data for reporting to management and driving continual improvement
• Communicate with regulatory agencies regarding establishment registration, product listing and current/new regulations
• Prepare and coordinate activities during internal and external Quality inspections
• Manage and maintain various quality system processes such as CAPA, equipment, reagent QC, document control, training, internal audit, supplier, non-conformance, etc.
• Train employees on the Quality system policy and procedures
• Review and approve SOPs, protocols and reports for validation, reagent stability and other studies
• Track and trend planned and unplanned deviations, out-of-specification quality control results, complaints, and corrective actions

Skills: QMS Management, Regulatory Compliance, Quality Auditing, CAPA Oversight, Risk Management, Data Analysis, SOP Review, Team Leadership

• Report all concerns about product quality
• Support the development, implementation, and continual improvement of the quality management system and ensure the integrity of the system is maintained when changes are implemented
• Establish and monitor the appropriateness of the quality policy, ensuring the quality policy is understood, implemented and maintained at all levels of the organization and that the quality objectives are fulfilled
• Ensure customer requirements are determined and met
• Identify and provide adequate resources and training to ensure effective work performance which includes meeting regulatory, statutory and customer requirements while also supporting and maintaining the effectiveness of the quality system
• Participate in formal reviews of the quality management system as planned
• Participate in Management Review meetings (at a minimum annually), to ensure that the Quality Management System (QMS) continues to remain suitable and effective
• Display continuous leadership skills in supporting the team and ensure continuous improvement is in place to produce high-quality, safe and legally compliant products to meet and/or exceed overall customer satisfaction
• Responsible for the governance of Quality and Food Safety Management process and takes charge of the overall implementation and maintenance of quality standards in the Plant
• Develop and maintain best practices in overall Quality and Assurance initiatives to ensure consistent customer satisfaction
• Responsible for managing the overall customer management process, providing constructive feedback and formulating professional responses to customer complaints
• Provide relevant training on quality systems and programs to ensure compliance with all quality processes/procedures
• Implement proactive assessments and recommend risk mitigation strategies through collaboration with the Plant Management team and direct observation of process controls

Skills: Quality Reporting, QMS Improvement, Policy Monitoring, Customer Focus, Training Delivery, System Review, Leadership Support, Risk Mitigation

• Implement process improvements to ensure GxP compliance in an early clinical development environment, with a strategic view to grow the Quality function as the products advance to late-stage development and potential commercialization
• Ensure the adequacy of the Quality Management System (QMS) components
• Creation and revision of SOPs and training programs for GxP compliance, and documentation of QMS-required training
• Ensure GxP technologies are validated and validation is maintained according to industry standards
• Represent Quality Assurance on cross-functional teams and serve as a resource for quality
• Compliance questions, issues, and planning across the development organization, including providing guidance based on current global regulations, industry standards, and best practices
• Work with internal R&D functions and external parties including development partners, consultants, contract auditors, CROs and investigator sites, to promote a high level of quality and consistency across and within programs
• Develop the risk-based audit and compliance strategy for all programs
• Oversee or lead inspection activities (preparation, conduct, and response) for regulatory inspections internally, and at investigator sites
• Facilitate internal reviews of processes, assist in the preparation of responses to findings
• Identify and address risk and implement preventative measures
• Assist in the development of corrective and preventative action plans following identification of compliance issues/concerns with both internal and external personnel (e.g., investigator sites and vendors)
• Monitor progress on successful completion, review/approve deviations and QA-Controlled procedures
• Participate in outsourcing vendor evaluation and selection, conducting vendor audits 
• Ensure robust vendor oversight and establish Quality Agreements

Skills: Compliance Oversight, QMS Management, SOP Development, System Validation, Audit Planning, Risk Prevention, Vendor Audits, Regulatory Guidance

• Provide expertise and guidance on GxP activities and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigation
• Lead investigations into significant quality issues, suspected scientific misconduct and suspected serious breach of GCP
• Facilitate identification of root cause and development of appropriate corrective and preventive actions
• Track actions and confirm effectiveness
• Ensure reporting of potential or confirmed violations to regulatory authorities
• Manage audit program for investigational sites, utilizing findings to improve procedures and/or coach clinical teams
• In collaboration with a subject matter expert, provide quality oversight related to GMP activities
• Oversight and approval of Method Validation, Release testing, and Stability for Drug Substance and Drug Product
• Work cross-functionally with CMC and CMOs to provide oversight and resolve quality investigations of issues that occur at contract manufacturing and testing organizations
• Review and approve CMO master documentation (e.g., specification documents, master batch records, label proofs, etc.)
• Review executed batch records, applicable test data (in-process and release) and perform product dispositions
• Work with Qualified Persons (QP) to support QP certification for distribution
• Maintain awareness and inform upper management of potential issues impacting business processes

Skills: GxP Guidance, Quality Investigation, Root Cause Analysis, CAPA Execution, Regulatory Compliance, Audit Program, Method Oversight, CMO Review

• Ensures the management and enhancement of the quality and standards framework essential to maintain the quality of student learning and teaching, as well as the standing and reputation of the Institute
• Designs and embeds a quality assurance culture within the Institute
• Formulates strategies, policies, systems, procedures, and practices for the Institute’s academic quality assurance and enhancement
• Develops policies and guidelines on teaching evaluation, program review, and student learning assessment
• Monitors, reviews, evaluates and develops institutional and program accreditation
• Reviews all materials sent to the Department of Education and Commission on Higher Education to reflect the quality standards of the Institute
• Spearheads any accreditation undertaking of the Institute
• Gathers and analyzes data to measure the performance of academic programs and provide metrics-driven recommendations to the management committee
• Develops tools to automate internal processes and forms
• Research and recommend program innovations in terms of course offerings, curricula, methods of instruction and tools (software, equipment, etc.)
• Continually build, evolve and integrate existing programs to uphold the mission of reinventing education to address the ever-changing needs of industry

Skills: Quality Framework, QA Culture, Policy Development, Teaching Evaluation, Accreditation Oversight, Data Analysis, Process Automation, Program Innovation

• Significant technical experience working with complex financial applications
• Background in technical test automation solutions from design to implementation
• Significant experience in Performance testing modern web applications
• Deep understanding of streaming data, client-side applications and micro-service layers
• Demonstrable agile / scrum testing experience managing large and remote QA teams
• Working knowledge of development toolsets e.g., GitHub, TeamCity, Nexus, Jira, Octopus, Ansible
• Strong leader and influencer in the quality assurance domain
• Development background with programming experience, client or server side
• Cloud infrastructure development experience e.g., AWS, Azure
• Previous management of QA Teams across manufacturing
• Experience working within Agile environments
• Experience of working in product companies
• Must have attention to detail and good investigation, problem-solving and organizational skills
• Ability to work effectively with people and communicate challenging information and obtain positive results

Qualifications: BA in Regulatory Affairs with 8 years of Experience

• Extensive experience within the software industry, a significant proportion of which in a hands-on QA and testing role
• Experience managing teams of highly technical QA and test staff
• Exceptional managerial and leadership skills, ability to motivate and lead personal development plans for employees 
• Experience in team sizing, capacity planning, common tooling strategy, mentoring, training plans creation and governance
• Experienced in coordinating others’ work to ensure the objectives of the Quality Assurance function are met
• Demonstrable experience in defining and implementing comprehensive test strategies for complex IT projects working in Agile environments
• Ability to work as part of a senior management group leading the Product Engineering programme
• Proven communication and presentation skills
• Ability to work with Microsoft Office applications
• Proficient in cGMPs applicability and decision making
• Ability to analyse problems, propose remedies and implement a solution
• Ability to react to changing requirements and adjust processes and approach
• Ability to recognise what needs to be done and complete it with minimal supervision
• Ability to work to tight deadlines

Qualifications: BA in Information Systems with 9 years of Experience

• Working experience as an experienced leader in Food Quality Assurance, Quality Systems, and/or Quality Operations
• Strong knowledge of global regulations 
• Experience successfully spearheading a pre-approval inspection
• Excellent organizational skills and attention to detail while successfully meeting deadlines in a fast-paced, start-up environment
• Strong understanding of the science/engineering behind ongoing experiments - the rationale, purpose, and appropriate analytical methods
• Exceptional communication skills including writing, presentation, influence, and negotiation skills
• Ability to lead and provide guidance to multiple projects simultaneously
• Demonstrated ability to build, develop, and lead a team of quality professionals in support of corporate goals
• Experience managing and working with third parties by effectively using strong interpersonal skills/diplomacy, and negotiation skills to influence and accomplish work
• In-depth understanding and application of industry standards and cGMP/international regulations and guidelines 
• Familiarity with risk-based approaches suitable for pharmaceutical development
• Demonstrated ability in decision making and providing direction to operators on next steps

Qualifications: BA in Business Administration with 4 years of Experience

• Experience with user load testing tools (e.g., Locust)
• Experience with testing in startup and/or scaleup environments
• Demonstrable experience within a Clinical Quality Assurance role, working within a Site Network, CRO or Pharma organisation
• Experience in devising and implementing policies, providing compliance advice and training
• Extensive knowledge of managing, maintaining and improving quality systems and procedures
• Significant experience in performing international clinical quality audits e.g. investigator site audits, vendor audits
• Experience in analysing data using Quality Metrics
• Previous experience in providing expert Quality Assurance advice, support and guidance to all sites including international affiliate sites
• Proven history of preparing, hosting and managing regulatory inspections e.g., MHRA, FDA including the training of staff and preparation of inspection responses
• Extensive experience in coordinating and hosting sponsor/CRO audits
• Strong knowledge of international GCP regulations and regulatory inspections
• Proven leadership of Quality Assurance initiatives and clinical governance activities

Qualifications: BA in Software Development with 5 years of Experience

• Extensive Quality Assurance Management experience
• Working experience as a QA Engineer/Software testing
• Hands-on experience on web-based applications/Mobile applications and working experience on REST API
• Knowledge and ability to implement Quality Management Systems and SOPs
• Able to effectively enable and drive change across cross-functional stakeholders
• Strong leadership and the ability to delegate work
• Good accuracy and attention to detail
• Experience in batch record review and manufacturing operations
• Strong knowledge of regulatory requirements about GMP/GDP
• Good knowledge of effective quality documentation systems
• Concise and persuasive in the description of the different QA situations
• Able to stick to the standard and not be pressured
• Ability to manage multiple projects at one time
• Excellent written and verbal communication skills

Qualifications: BA in Risk Management with 3 years of Experience