Cleaning Squad Lead:
The Squad Lead for Cleaning Validation & Cleaning Operations has the responsibility to co-lead (in partnership with the local process owners) the effort to bring all existing cleaning validation and cleaning operations efforts on the Geel site in line with current industry best practices (including the dimension of risk management). On-site presence is required for min 80%.
Essential duties and responsibilities
* Provide direction on cleaning validation and cleaning operations best practices and corresponding science-based risk management approaches
* Oversee the various projects and corresponding resources (contractors), applying diligent project management practices and controls, to assure delivery vs plan
* Assure quality and compliance (with internal and external regulatory requirements) of projects outputs & deliverables, while closely partnering with the corresponding QA lead to assure full alignment
* Drive change management to the broader organization to assure sustainable adoption of best practices
* Mentor and coach the Local process owner (LPO) to uplift his/her knowledge to reflect industry best practices
Required qualifications:
* Deep understanding and experience of equipment cleaning and cleaning validation in a pharma manufacturing environment
* Experience in API environment preferred
* Deep understanding of both FDA and EMA requirements towards cleaning and cleaning validation, including hands on experience with risk-based approaches and creation of validation documents.
* Excellent project management skills, organizing, planning and coordination skills
* Strong interpersonal & communication skills
* Experience in leading teams in complex / dynamic environments
* Coaching, human change management and training skills
* Ability to navigate politics, interact at different levels of the organization, and influence without authority
* Languages; English (must), Dutch (preferred)