Stark Pharma Solutions Inc
Overview
Job Title:
Quality & Compliance Lead
Location:
Boston, MA
Duration:
12+ Months (Contract)
Experience:
5 8 Years (Total up to 10 Years) We are seeking an experienced
Quality & Compliance Lead
to manage, author, and oversee validation and quality activities across multiple projects within a regulated pharmaceutical environment. The ideal candidate will have a strong background in
Computer System Validation (CSV)
and
Commissioning, Qualification & Validation (CQV) , with proven expertise in maintaining compliance with regulatory frameworks and industry standards. Responsibilities
Documentation & Deliverables
Develop, author, and maintain comprehensive validation and quality documentation, including protocols, reports, risk assessments, SOPs, and related deliverables. Ensure all validation documentation complies with FDA, EMA, GxP, and other applicable global regulatory standards. Review, approve, and ensure accuracy and completeness of validation documents to align with project objectives and regulatory compliance requirements. Maintain organized documentation and support audit readiness through proper document control and traceability. Project Management
Lead and manage multiple validation and quality projects simultaneously from planning to execution. Define project scope, deliverables, and timelines, ensuring clear communication across internal and external stakeholders. Identify potential risks early, propose corrective or preventive actions, and implement mitigation strategies to maintain project timelines. Conduct regular project meetings and status reviews, providing detailed progress reports to leadership and stakeholders. Collaborate closely with Quality Assurance, IT, Engineering, and Manufacturing teams to ensure project alignment and successful validation outcomes. Compliance & Technical Expertise
Ensure all validation activities meet GxP, FDA 21 CFR Parts 11, 211, and 820, and industry best practices (ISPE, GAMP 5). Act as a subject matter expert (SME) for validation methodologies, quality systems, and regulatory compliance. Support internal and external audits and inspections, providing technical documentation and clarification as needed. Contribute to continuous improvement by identifying opportunities to streamline validation processes and enhance quality system efficiency. Required Experience & Skills
5 8 years of relevant validation experience within the pharmaceutical or biotech industry. Proven hands-on experience in IT Computer System Validation (CSV) and CQV for process and laboratory equipment. Strong understanding of regulatory frameworks, including FDA 21 CFR Part 11, 211, 820, and global compliance guidelines. Proficiency with validation and quality documentation tools such as Veeva Quality Docs, ServiceNow, JIRA, and Kneat. Demonstrated experience authoring validation protocols, reports, and risk assessments. Strong project leadership skills with the ability to manage multiple projects in parallel. Excellent communication and stakeholder management abilities.
#J-18808-Ljbffr
Job Title:
Quality & Compliance Lead
Location:
Boston, MA
Duration:
12+ Months (Contract)
Experience:
5 8 Years (Total up to 10 Years) We are seeking an experienced
Quality & Compliance Lead
to manage, author, and oversee validation and quality activities across multiple projects within a regulated pharmaceutical environment. The ideal candidate will have a strong background in
Computer System Validation (CSV)
and
Commissioning, Qualification & Validation (CQV) , with proven expertise in maintaining compliance with regulatory frameworks and industry standards. Responsibilities
Documentation & Deliverables
Develop, author, and maintain comprehensive validation and quality documentation, including protocols, reports, risk assessments, SOPs, and related deliverables. Ensure all validation documentation complies with FDA, EMA, GxP, and other applicable global regulatory standards. Review, approve, and ensure accuracy and completeness of validation documents to align with project objectives and regulatory compliance requirements. Maintain organized documentation and support audit readiness through proper document control and traceability. Project Management
Lead and manage multiple validation and quality projects simultaneously from planning to execution. Define project scope, deliverables, and timelines, ensuring clear communication across internal and external stakeholders. Identify potential risks early, propose corrective or preventive actions, and implement mitigation strategies to maintain project timelines. Conduct regular project meetings and status reviews, providing detailed progress reports to leadership and stakeholders. Collaborate closely with Quality Assurance, IT, Engineering, and Manufacturing teams to ensure project alignment and successful validation outcomes. Compliance & Technical Expertise
Ensure all validation activities meet GxP, FDA 21 CFR Parts 11, 211, and 820, and industry best practices (ISPE, GAMP 5). Act as a subject matter expert (SME) for validation methodologies, quality systems, and regulatory compliance. Support internal and external audits and inspections, providing technical documentation and clarification as needed. Contribute to continuous improvement by identifying opportunities to streamline validation processes and enhance quality system efficiency. Required Experience & Skills
5 8 years of relevant validation experience within the pharmaceutical or biotech industry. Proven hands-on experience in IT Computer System Validation (CSV) and CQV for process and laboratory equipment. Strong understanding of regulatory frameworks, including FDA 21 CFR Part 11, 211, 820, and global compliance guidelines. Proficiency with validation and quality documentation tools such as Veeva Quality Docs, ServiceNow, JIRA, and Kneat. Demonstrated experience authoring validation protocols, reports, and risk assessments. Strong project leadership skills with the ability to manage multiple projects in parallel. Excellent communication and stakeholder management abilities.
#J-18808-Ljbffr