Commissioning & Qualification (C&Q) Lead

As part of the creation of a new dry form building, the C&Q Lead has the overall management responsibility of the C&Q Firm who will be responsible for Design Qualification, Factory Acceptance Tests, Site Acceptance Tests, Commissioning, Qualification, Hand Over, and Close Out.

Key Responsibilities

• The C&Q Lead will provide oversight of the site commissioning and qualification organization in support of capital projects. The incumbent in this role will lead and manage an experienced team of colleagues and contractors focused on commissioning and qualifying facilities, utilities, dry forms process equipment and Computerized System
• The individual oversees C&Q work activities of major complexity to ensure on time and within budget completion.
• Responsible for driving the commissioning and qualification activities of a new facility (incl. Utilities, equipment, CSV, ...) according to standards and regulatory requirements.
• Lead a team of colleagues and contractors to achieve C&Q objectives aligned with capital project milestones and site goals.
• Approval the C&Q Firm deliverables.
• Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
• Interface with multiple sites and departments (Engineering, Technical Services, MS&T, end user groups, QA, suppliers, Architectural / Engineering Contractor, Construction Management contractor, Asset Care Management contractor, and C&Q contractor) to accomplish predefined goals and to provide technical guidance including but not limited to facilities, utilities, building equipment, production dry forms equipment, automation, cleaning approach and Computerized System validation.
• Design and author the validation/qualification approach (plan), provide the scientific rationale and acceptance criteria, generate and review/approve commissioning, validation/qualification protocols/reports.
• Conduct, and assist others, in industry and regulatory research including research into industry standards/FDA guidelines for validation equipment / processes and make determinations regarding acceptance criteria and testing.
• Lead/support the project team, coordinate the execution of C&Q of the project, prepare project schedules and provide presentations to senior management / stakeholders on project status.
• Lead/support the completion of complex investigations, initiate change controls (incl. assessing impact of the change) and managing corrective action plans associated with C&Q activities
• Lead/Support the implementation of structures, tools, and processes to actively manage C&Q activities.
• Participate when required during internal and external audits forwhich they are a SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation

Qualifications & Experience

• Minimum of 10 years of relevant pharmaceutical industry experience (with a focus on dry forms pharmaceutical application validation in a GMP environment).
• Minimum 10 years ‘experience in managing personnel and/or complex projects, including direct experience in managing different Commissioning/Qualification/Validation contractors and activities for large and complex projects.
• Strong problem-solving skills, strong verbal and written communication skills.
• Ability to work independently and to influence and work across organizational boundaries.
• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
• Excellent command of English and preferably French language.
• Project and change management experience. Experience with Product Life Cycle Management.
• Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.) with direct interactions including face to face interaction and response to audit questions.

The successful C&Q Lead candidate should have around 10+ years of industry experience, with project experience including green and/or brownfield projects in the pharmaceutical dry forms industry.

In general, the selected C&Q Lead will be directly collaborating with the rest of the project core team, project controls, and site validation teams to direct the implementation of the project. Experience with the similar project management process, documents, and deliverables is advantageous.

While the capital project manager will remain responsible for seeking funding approvals within the team and overseeing the success of the project, the C&Q Lead will be responsible for executing required steps within the Stage Gate project management process and ensuring successful collaboration with the rest of the project team. Additionally, the C&Q Lead will be the key driver in developing and updating the C&Q project budget/estimate and schedule, especially in the design phase and into the construction and C&Q phases.

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