Job Description
The Change Control Lead plays a pivotal role in ensuring the site's compliance with regulatory requirements and meeting all change control needs. This includes being responsible for planning and executing all change control activities for site projects, as well as promoting Good Manufacturing Practice (GMP) awareness on site.
The incumbent will be accountable for ownership and management of changes associated with large strategic projects, including those related to processes such as equipment, automation, and supply chain or other technical functions as required. They will also be responsible for initiation, ownership, and management of changes through the change control systems.
The Change Control Lead will collaborate with change initiators, subject matter experts, reviewers, approvers, and external manufacturing groups throughout the life cycle of relevant changes. Additionally, they will obtain approval for change from relevant review boards and conduct impact assessments for relevant changes.
Liaising with stakeholders for impact assessment and task identification is also an essential part of this role. The Change Control Lead will align system release strategy with stakeholders/operations and identify and implement process optimization opportunities where they arise.
Maintaining accurate task scheduling per project requirements and minimizing the number of overdue tasks through schedule management are key responsibilities. Engagement with the tier process to escalate changes or tasks that are off track is also a critical function of this role.
Frequent safety and quality walkdowns, as required, will be conducted by the Change Control Lead to ensure compliance with regulations and standards.
Required Skills and Qualifications
* Understanding of unit operations and plant equipment
* Understanding of validation (process and cleaning)
* High-level understanding of regulatory requirements as they relate to change control
* Understanding of quality policies and procedures
* Understanding of GMP and GDP practices
* Knowledge of safety and environmental procedures
* Proficiency in using digital systems for full digitization of change control execution
* Familiarity with project life cycle delivery
Benefits
This role offers excellent career growth opportunities for individuals who are passionate about change control and regulatory compliance. As a Change Control Lead, you will have the opportunity to work on high-profile projects and develop your skills in a fast-paced environment.
Others
A minimum of 3-8 years' experience is required for this role, preferably in a project environment. A strong emphasis on change control documentation, a GMP/GDP background, and a degree in a science and/or engineering-based discipline are also highly desirable.