Senior Manager QC Lab Services and Projects

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Job Description:

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

Essential Job Duties and Responsibilities

The Senior Manager QC Lab services and projects is responsible for all processes and activities needed for the day-to-day operations of the QC Advanced Therapies laboratories in Leiden. The Sr. Manager QC Lab services and projects is leading a team of internal specialists and on-site teams from external suppliers to deliver the services to the QC lab. Functions and activities within the department comprise the full spectrum of QC Services (e.g. Lab Supplies Equipment Life Cycle Management QC Lab Facilities and Lab changes QC Automation Data Integrity Lab Safety etc.). Besides QC Services the Sr Manager QC will lead initiate and participate in local and global capital investment projects to keep the department compliant and in line with future needs.

The ideal candidate has hands on experience and a good knowledge of the cGMP regulations for lab equipment validation software validation and data integrity. The Senior Manager QC Lab services will act as the go to person for these topics and will need to train and mentor the team members in these areas.

Principal responsibilities

• Leading the lab services team responsible for lab equipment introduction and life cycle management including all automation necessities.

• Project portfolio management including OPEX/CAPEX LRFP.

• Provides leadership to EHS departmental ambassadors and SPOCs

• Leads facility (Offices & Labs) related projects or initiatives with stakeholders for the department.

• Coordinates the in-house services providers for lab material replenishment and general assistance to the labs.

• Primary contact for all facility related topics and a leading role in (major) QC facility improvement and expansion projects.

• Achieving excellence in business processes. Identify and support continuous improvement efforts in collaboration with the QC management.

• Ensuring that data is generated and maintained according to current regulatory requirements including data integrity.

• Accountable for the team performance. Act as a Servant Leader to coach and develop team members to become successful in talent development and business performance.

• Setting goals and objectives for the department and define Key Performance Indicators that are indicative for excellent performance.

• Ensures that GMP/GLP guidelines compliance best practices EHSS regulations are followed by team members.

• Responsible for the efficient and effective functioning of the team ensuring activities are in line with the timelines resources and budget.

• Responsible for the adequate qualified/ trained resources available for the activities needed in his/her team. Recruitment and hiring of personnel ensuring proper onboarding and training.

• Evaluates performance and provides opportunities for growth conduct performance appraisals and ensure alignment of G&O of direct reports to the company objectives.

Minimum qualification

Manager

Bachelors degree in relevant discipline with 8-10 years related experience.

Previous supervisory experience needed.

• Ability to work with and lead others in a team environment.

• Strong communication skills

• Implementing the Leadership imperatives (connect shape and grow)

• Advanced knowledge of Quality Control processes and quality systems

• Advanced knowledge of regulatory requirements policies and guidelines.

• Affinity with principles of Business Excellence.

Sr Manager

Bachelors degree in relevant discipline with 10 years related experience.

At least 5 years in a supervisory position.

In addition to Manager other requirements:

• Detailed knowledge of financial concepts and terminology associated with capital project/budget responsibilities of the position.

• Ability to independently manage a portfolio of ongoing projects.

• Greater degree of impact on the business results and responsibility for managing a group of professionals.

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Preferred Skills: