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Validation Manager

Your Role

You will be responsible for defining and executing the validation strategy for the Madison and Verona sites in accordance with the appropriate GMP requirements for an API Contract Manufacturing Organization.  You will lead the Validation team to ensure the execution of validation activities. Validation activities include qualification and re-qualification of facilities, equipment, computer systems, utilities, equipment cleaning, cleanroom qualification, and process validation. Provides subject matter expertise on validation activities including but not limited to, qualification and re-qualification of facilities, equipment, computer systems, utilities, cleaning (facility and equipment), and process validation. Active participation with site projects and multi-disciplinary teams with Manufacturing, Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance to ensure successful implementation and coordination of validation activities. Direct interaction with customers to understand specific validation requirements, ensuring customer needs are met specifically as an API Contract Manufacturing organization. Responsible for the successful validation and qualification of sub-contractors assuring subcontractors meet the pertinent product, regulatory and corporate quality requirements. Provide leadership and supervise activities and work assignments for validation activities at the site such as:

 

  • Maintain Site Validation Master plan.
  • Generates the Validation schedule, drives execution of workload and monitors performance to plan and tracks status of validation activities and documentation.
  • Approves validation protocols prior to execution of work, ensuring content is accurate and in a timely manner to meet schedule requirements.
  • Plan and adhere to qualification and requalification schedules. Establish and maintain system lifecycle documentation (e.g. Validation Plans/URS/FRS/IQ/OQ/PQ/FAT/SAT/TM) and associated final reports.
  • Evaluates data from executed validation protocols and ensures summary reports are generated and approved, Ensuring quality, accuracy, and completeness of commissioning, qualification, and validation documentation and deliverables.
  • Generates or approves Quality Risk Assessment documents in relation to executed validation activities.
  • Assesses and closes deviations related to closure of validation activities and raises CAPA’s as required.
  • Actively participates in relevant change control activities and risk evaluation systems as they pertain to validation.

 

Who you are:

Minimum Qualifications:

Basic Qualifications

  • Bachelor’s degree in an Engineering or Life Sciences discipline.
  • Minimum five years’ experience of a similar role within a cGMP environment is essential, complimented with basic project management knowledge
  • 5+ years of leadership (team lead, supervisor, manager) with a proven track record of motivating and managing a team of graduate level staff.
  • Must be able to apply a risk-based approach to operation and interpretation of resulting data.

Preferred Qualifications:

  • Experience in interaction with regulatory bodies and development of audit responses preferred.
  • Knowledge of API products and CMO is desirable but not essential.
  • Ability to liaise with customer and intercept their requirements. 
  • Innovative, decisive, results-oriented leader with strong coaching and problem-solving skills.
  • Ability to multitask and prioritize independently in a fast-paced environment.
  • Demonstrated ability to supervise and develop staff and work effectively will all levels of organization.
  • Excellent interpersonal, communication, and writing skills, ability to analyze technical issues, define/solve problems, establish project plans, statistically evaluate solutions, and draw valid conclusions.
Job Requisition ID:  205000
Location:  Madison
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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