CSV Validation Lead

TechDigital Group; Princeton (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

TechDigital Group in Princeton, NJ seeks a seasoned Validation Lead to helm pharma/biopharma/medical devices validation and compliance programs, including CAPA, deviations, audit management, and GxP governance.

You will apply 12–15 years of experience, hold a B-Tech/Engineering/MBA or equivalent, and drive SDLC adherence to GAMP5, 21 CFR Part 11 and Annex 11, plus ISO 13485/ISO 9001/ISO14971 across IT services.

Qualifications

• Must have 12-15 years of Validation & Compliance experience in pharma/biopharma/medical devices.
• B-Tech/Engineering/MBA or equivalent degree.
• Proven experience in Application Maintenance and Development, Validation Testing, Audit Management, CAPA and Deviation.
• Good understanding of pharma GxP environment and enabling emerging technologies for GxP compliance.
• Knowledge in establishing standards such as ISO 13485, ISO 9001 & ISO14971 guidelines for Pharmaceuticals, Biopharma and Medical devices in IT service industry.
• Understanding of the regulated software development life cycle (SDLC) as per GAMP5, GxP, 21 CFR Part 11 and Annex 11 compliance.
• Maintaining customer relationship and manage expectations and escalation COE Project Management, around Governance, Demand Management, Estimation & Sizing.

Responsibilities

• Maintain customer relationships and manage expectations and escalations in COE Project Management.
• Support governance, demand management, estimation and sizing activities.
• Lead architecture, design and development with a high-performing team.
• Ensure knowledge updation and adoption of new technologies for quality and compliance.
• Review architecture and design deliverables to meet industry best practices and compliance.

Skills

Validation & Compliance

CAPA & Deviation

GxP compliance

GAMP5

21 CFR Part 11

Annex 11

ISO 13485

ISO 9001

ISO14971

Customer relationship management

Education

B-Tech/Engineering/MBA or equivalent degree

Job description

Mandatory Skills

CSV/ Compliance and Assurance services/ Validation Testing/ Audit Management/ CAPA and Deviation/ Pharma GxP/ Biopharma and Medical devices/ GAMP5, GxP, 21 CFR Part 11 and Annex 11 compliance

Job Qualifications

• - Validation Lead:
• Must have Skills12-15 years of Validation & Compliance experience.
• B-Tech/Engineering/MBA or equivalent degree.
• Proven experience in Application Maintenance and Development, Validation Testing scope of work, Audit Management , CAPA and Deviation.
• Good understanding of pharma GxP environment and enabling emerging technologies for GxP compliance.
• Knowledge in establishing standards such as ISO 13485, ISO 9001 & ISO14971 guidelines for Pharmaceuticals, Biopharma and Medical devices in IT service industry.
• Understanding of the regulated software development life cycle (SDLC) as per GAMP5, GxP, 21 CFR Part 11 and Annex 11 compliance.
• Maintaining customer relationship and manage expectations and escalation COE Project Management, around Governance, Demand Management, Estimation & Sizing.

Good to have Skills:

• Proactive and problem-solving mentality with strong analytical skills.
• Good written and verbal communication skills to effectively communicate with technical and business usersA self-motivated individual with a genuine passion for Compliance & Validation Role.
• (1.) To bridge the gap between client needs and business goals by gathering requirements, crafting innovative solutions with deep domainortechnology expertise, and driving successful implementations that propel strategic initiatives.
• (2.) To spearhead the architecture, design, and development (through a high-performing team) of innovative solutions for productorproject and sustenance delivery, ensuring alignment with strategic objectives.
• (3.) To ensure knowledge up-gradation and work with new technologies so that the solution is current and meets quality standards and the client requirements.
• (4.) To review architecture and design deliverables and ensure solutions adhere to industry best practices ,architectural standards simultaneously establish and enforce governance orcompliance measures.
• (5.) To train and develop team so as to ensure that there is an adequate supply of trained Client in the said technology and delivery risks are mitigated.