Commissioning & Qualification Program Lead

A healthier future. That's what drives us. Always innovating, we bring together dedicated people and diverse perspectives from across our global network, empowering each other to keep breaking new ground. That's what makes us who we are. That's what makes us Roche.

This role is based in Pharma Technical Operations Technology (PTT), an organization that is responsible for ensuring Pharma Technical Operations (PT) stays at the forefront of technology in our current and future facilities. PTT, composed of global MSAT and Engineering, realizes new assets for the PT manufacturing network of drug substance, drug product, and device industrialization facilities. You will have the opportunity to build manufacturing facilities that deliver life saving medicines to patients.

As the Commissioning & Qualification (C&Q) Program Lead you will be responsible for managing the C&Q activities in a large greenfield CAPEX project, which will consist of several new buildings in the program. You will be responsible for building a team with overall responsibility for the compliant, on time and budget delivery of C&Q deliverables needed to deliver medicines to patients on time. The position requires excellent internal and external collaboration and influencing skills and the ability to lead diverse, cross-functional teams. As part of the project leadership team:

• 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.

Education & Experience

• A BA/BS/MS in Engineering, Science or related discipline with 20 or more years of experience preferable in pharmaceutical/biopharmaceutical industry.

• Experience in management of C&Q scope in capital projects (preferably drug product).

• At least 15 years experience building and leading teams on large complex CAPEX projects.

• Working experience in Manufacturing, Qualification / Validation / Engineering or related areas at a sterile drug product manufacturing site.

• Able to execute scope that is complex on projects that are mid to large-sized.

• Broad understanding of the principles of various engineering disciplines.

Knowledge/Skills/Competencies

• Excellent collaboration, teambuilding and communication skills.

• Understands facility end user operational needs and principals. Understands and is an advocate for End-User organizations to assure that the project meets or exceeds all compliance requirements and functional needs. Ability to create a collaborative "one team" environment.

• Vast experience in the Commissioning, Qualification and Validation including systems and equipment within the following areas: sterile drug product manufacturing, packaging/warehousing, GMP & Non-GMP utilities and facilities, automation systems / Computer System Validation.

• Planning and Execution of Projects: Systems & Equipment C&Q strategies / ASTM E2500, risk based approach, C&Q document development and execution, application of industry standards and best practices.

• In-depth pharmaceutical knowledge, global regulations and industry standards (FDA, EMA, ICH,...).

• Proven expertise in effectively applying and/or developing advanced project management tools and methodologies, innovative mindset, willingness to engage in new project management techniques.

• Passion to continuously improve and lifelong learning.

• In addition, you bring the following competences and skills:Global experience and culturally savvy, can adapt to and effectively navigate in various cultural environments and organizational levels including executive management.

• Travel (20%) may be required to meet the business need, in order to lead the team at the project site/location. Expectation if assigned to a specific project the candidate will spend most of their time on site during design throughout commissioning and qualification.

This is a 100% full time role and preference is for locally based candidates in Holly Springs, NC.

Relocation benefits are available for this posting.

The expected salary range for this position based on the primary location of North Carolina is $138,300 - $256,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

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Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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