Kiniksa Pharmaceuticals
Manager, Quality Assurance Validation
Kiniksa Pharmaceuticals, Lexington, Massachusetts, United States, 02173
Reporting to the Director QAV/CSV, the Manager, QAV will manage validation activities related to the Quality oversight of facilities, utilities, equipment, computerized systems and information. The role is responsible for establishing, tracking, and trending metrics to achieve Quality outcomes that ultimately drive continuous improvement working across the matrix organization with business process owners, other key stakeholders, and subject matter experts.
This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities (including, but not limited to):
Quality Assurance Validation (QAV) Responsibilities:
Manage the sustainability of the GMP facilities, process and lab equipment by providing Quality oversight throughout each system lifecycle, assuring each system remains in a state of control.Identify and track progress against key project milestones, partnering with applicable business process, equipment, and facilities owners along with external providers to assure overall project success and complianceDefine and lead the development of metrics to track effective and efficient completion of qualification, maintenance and calibration activities throughout each system lifecycleWork closely with business process owners to assure process equipment and utilities periodic reviews are completed in a timely manner to demonstrate systems have remained in a controlled, validated state and are fit for useComputer System Validation (CSV) Responsibilities:
Manage preparation of all validation deliverables, including authoring, executing, and approving validation plans, design specifications, user requirements/trace matrix, test scripts, and validation summary reports; resolving deviations identified during test executionMaintain master list and manage periodic reviews of Kiniksa’s GxP computerized systemsSupport vendor audits and supplier approval process with respect to CSVSupport computer system risk-based assessments, gap assessment remediation activities, as well as Audit Trail review activities for all GxP systems.Qualifications:
Requires a bachelor’s degree with 6+ years’ industrial experience, or an equivalent combination of training and experience.Demonstrated knowledge of relevant Quality Management Systems (QMS) as well as compliance processes and regulations, e.g., Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and GxP regulations (21 CFR Part 11, Annex 11 & GAMP5, etc.)Familiar with electronic quality system tools (e.g., Veeva Vault)Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting prioritiesExcellent teamwork, technical, and interpersonal skills, with the ability to communicate and collaborate with culturally and geographically diverse employees and management at all levels, and through various formats (e.g., presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.)Strong commitment to compliance and ethical standards
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities (including, but not limited to):
Quality Assurance Validation (QAV) Responsibilities:
Manage the sustainability of the GMP facilities, process and lab equipment by providing Quality oversight throughout each system lifecycle, assuring each system remains in a state of control.Identify and track progress against key project milestones, partnering with applicable business process, equipment, and facilities owners along with external providers to assure overall project success and complianceDefine and lead the development of metrics to track effective and efficient completion of qualification, maintenance and calibration activities throughout each system lifecycleWork closely with business process owners to assure process equipment and utilities periodic reviews are completed in a timely manner to demonstrate systems have remained in a controlled, validated state and are fit for useComputer System Validation (CSV) Responsibilities:
Manage preparation of all validation deliverables, including authoring, executing, and approving validation plans, design specifications, user requirements/trace matrix, test scripts, and validation summary reports; resolving deviations identified during test executionMaintain master list and manage periodic reviews of Kiniksa’s GxP computerized systemsSupport vendor audits and supplier approval process with respect to CSVSupport computer system risk-based assessments, gap assessment remediation activities, as well as Audit Trail review activities for all GxP systems.Qualifications:
Requires a bachelor’s degree with 6+ years’ industrial experience, or an equivalent combination of training and experience.Demonstrated knowledge of relevant Quality Management Systems (QMS) as well as compliance processes and regulations, e.g., Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and GxP regulations (21 CFR Part 11, Annex 11 & GAMP5, etc.)Familiar with electronic quality system tools (e.g., Veeva Vault)Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting prioritiesExcellent teamwork, technical, and interpersonal skills, with the ability to communicate and collaborate with culturally and geographically diverse employees and management at all levels, and through various formats (e.g., presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.)Strong commitment to compliance and ethical standards
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.