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Commissioning & Qualification Program Lead at Genentech

Holly Springs, North Carolina, USA -

Full Time

Start Date

Immediate

Expiry Date

05 Dec, 25

Salary

256800.0

Posted On

06 Sep, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Executive Management, Communication Skills, Travel, Metrics, Capital Projects, Leadership Skills, Kpi, Design, Lifelong Learning, Regulations, Product Manufacturing, Addition, Packaging, Validation, Management System, Working Experience, Ema, Global Experience

Industry

Information Technology/IT

Description

Responsibilities

Build and lead the project team, motivating them through your strong communication and leadership skills with clear decision-making to maintain project flow.
Develop the multifaceted C&Q strategy necessary to deliver the various types of facilities within the program (Critical utilities, Filling, Assembly, Packaging, Admin/QC, Warehousing)
Model collaboration through strong partnership with the Project Management Team, Engineering Team, User Team and Quality and other key stakeholders in the project.
Develop C&Q execution strategies in alignment with Pharmaceutical Quality Management System, global standards and processes and regulations.
Responsible for C&Q cost estimates, detailed schedules, clear roles and responsibilities.
Manage C&Q resourcing incl. bid packages and supporting procurement activities.
Manage C&Q project scope to approved budget and schedule.
Ensure deployment and management of an effective (Contractor) safety program, meeting Roche requirements and metrics/KPI’s throughout the C&Q project lifecycle.
Provide regular status updates including progress vs plan, resource demand and schedule update, risks, mitigations.
Support handover activities