Global Quality Validation Lead
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Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.
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Reporting to the Head of Global Compliance & QMS, the Global Quality Validation Lead will oversee the Corporate Validation Program at a functional level. Most importantly, this individual will establish and oversee the corporate validation program while providing subject matter guidance, for all equipment, utility, production processes and laboratory GxP equipment systems, including computerized systems and data integrity.
Owning the Validation Program of the corporation as it relates to regulated products and critical systems, the incumbent will work closely with functional operations and/or engineering leads, ensuring activities involving the selection of equipment/systems, commissioning, qualification, and/or validation of systems and processes are performed in compliance to standards and GxP requirements applicable to Church & Dwight Co.
Role Accountabilities and Responsibilities (Describe the 5-7 major accountabilities)
- Enhance, oversee, and maintain the overall C&D Validation program, including C&D Policy, Global procedures and templates.
- Provide leadership in Validation to ensure that C&D sites meet the regulatory expectations for cGMP manufacture of products and are aligned with industry expectations.
- Set direction and provide leadership in the areas of process validation, cleaning validation, equipment qualification, laboratory systems validation, and all other aspects of the Validation Program.
- Oversee, assess, approve, and generate validation documentation including validation master plans, User Specific Requirements, determination of CSV and associated electronic records regulations applicability, plans, protocols, execution and reports.
- Management of validation life cycle to ensure ongoing validated state through oversight of the execution of validation studies for processes, cleaning, systems and equipment qualification as required.
- Managerial responsibilities include team development through coaching and training with the objective to have a cross-functional group that works well in a cross-functional environment.
- Set strategic and technical goals for the Validation program, providing continuous improvement in the areas of cleaning validation, equipment qualification, and process validation.
- Provide direction and set goals to ensure compliance with all aspects of the Quality Management System for Validation ensuring a state of inspection readiness.
- Serve as the lead for Validation during regulatory inspections.
- Support validation team defining validation strategy and approaches assuring validation initiatives are performed with scientific and statistical justification (as applicable).
- Serves as the validation SME for review/approval of deliverables associated with equipment systems and processes. This includes the URS, tech transfer, qualification, validation and revalidation activities.
- Ensure that there is adequate rationale defined for the closure of generated non-conformances, discrepancies and deviations associated with qualification/validation execution efforts.
- Performs risk assessments related to validated state of equipment, systems and processes.
- Performs duties related to Quality Management Systems, as assigned.
Education and Experience
- B.Sc./M.Sc. degree in relevant Science or Engineering from accredited institution in related field
- Minimum of ten (10) years’ experience in Commissioning, Qualification and/or Validation functions
- Experience with implementing and overseeing validation programs in a commercial manufacturing plant.
- Expertise in GxP compliance in consumer products, medical device, and/or pharmaceutical industries
- Experience with QMS, e-QMS and validated software
Skills and Competencies
- Strong knowledge with manufacturing quality (manufacturing, packaging, facilities, critical systems, automation, validation, etc.)
- Strong knowledge in Risk Management
- Demonstrated ability to work cross-functionally, to develop and maintain strong partner relationships
- Strong analytical and problem-solving skills and critical thinking abilities
- Continuous improvement mindset, detailed oriented and organized
- Ability to communicate clearly in an engaging manner with colleagues of various levels of experience and management
- Ability to prioritize, be proactive, meet deadlines, and be a team player
- Ability to work independently with minimal supervision
- Good verbal and written communication and presentation skills
COVID VACCINE REQUIREMENT*: To support the health and safety of our team members, successful candidates for employment in this role must (1) be fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) and to have submitted proof of vaccination status, or (2) request and receive an approved accommodation based on medical circumstances or sincerely held religious beliefs, practices or observances.
*Only applicable for Corporate positions based in Princeton, NJ and Ewing, NJ
Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.
For more information on our company, our brands and our culture visit us at http://www.churchdwight.com/
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DIVERSITY At Church & Dwight
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