Global Quality CAPA Lead
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Job Title: GLOBAL CAPA Lead
Department: Global Quality
Reports To: Sr. Manager QMS
Reporting to the Global QMS Head, the Global Quality Area Lead (change control, document control/training, CAPA) is responsible for contributing to the development and implementation of a technical QMS area of Church & Dwight’s global Quality Management System for all Church & Dwight sites globally. The position ensures all applicable regulations & standards across all 15 Power Brands, in Medical Devices, Drug/ Homeopathics, Food / Feed / SPD, Nutritional Supplement, Cosmetics, and Household regulatory classifications, and all regions (globally) are up to date, aligned, understood and followed by all functions involved in GMP activities, including R&D, Supply Chain, Marketing, Legal, Sales, and IT. This position is responsible for setting the direction, gaining alignment and implementing globally harmonized processes, including electronic systems, standardized metrics for reporting to the ELT, impacting
over all C & D sites. This position is responsible for influencing all levels of management, including the ELT, of business needs to ensure an appropriate level of quality and compliance risk across Church & Dwight. This role is responsible for managing, developing and coaching a staff of 10 people.
Role Accountabilities and Responsibilities
· Ensure CAPAs are written in accordance with the companies & Notified Body & GMP standards; throughout the Provider's engagement while adhering to the companies and cGMP standards
· Implement necessary follow-up verification checks on investigation, Corrective and Preventive Action items, ensure timely follow-up and approval occur throughout term of the CAPA process.
· Investigate Root Cause, write and implement CAPAs and interact with necessary departments and people to get the job done; must respond timely to deliver quality investigations and thorough CAPAs throughout the term of the project.
· Coach Company colleagues, facilitate a focused knowledge transfer regarding quality investigations regularly throughout the term of project.
· Review Company's SOPs related to the quality investigational system and assist with improvement/revisions in a timely manner throughout term of project.
· Attend any investigational related meetings as required
· Ensure PQM number of licenses is adequate and used as needed
· Train new users and super users (SME Role)
· Coach Company colleagues to facilitate a focused knowledge on Medical Device CAPA terminology and process as described in 21CFR820.100, ISO13485, and MDSAP in accordance with C&D’s QEP and SOP
· Responsible for reviewing, analysis of trends and reporting of quality performance to senior management via CAPA Review Board
· Work with Quality partners in development of metrics and prepare CAPA summaries
· Assist in execution of containment, investigation, root cause, action, and verification of effectiveness write-up and approvals for Quality System CAPAs on a timely basis; understand interaction between quality systems
· Development of CAPA verification of effectiveness with applying sampling statistical rationale
· Retrospective reviews of quality records as part of remediation
· Ensure compliance of CAPA program
· Schedule and lead the Corporate CAPA Board and support local CAPA Boards
Strategy and Functional Expertise
· Knowledge of policies, procedures and metrics
· Standard computer based software knowledge
· Keeps accurate documentation and submits detailed reports to appropriate executives
· Skills in data analysis to report and present effectiveness of business processes
· High attention to detail, organization and accuracy
· Math abilities and working knowledge of data analysis/statistical methods
Leadership and Influence
· Well organized and demonstrates forward leaning and high initiative
· Ability to influence cross functionally to deliver against business goals and objectives
· Leads and directs strategic programs focused on meeting regulatory company requirements
· Manages and develops other members of the team
· Mentors others in technical areas of expertise
· Demonstrates broad business orientation
· Shows personal commitment to the vision and creates energy and optimism
Program Development/Program Management
· Tests, confirms and/or improves processes to ensure they are in control and being followed
· Monitors project progress and sets deadlines and budgets
· Solves issues quickly and efficiently
· Ensures Stakeholder Satisfaction
· Delivers project tasks on time
· Works cross-functionally to identify and communicate regulatory requirements
· Works cross-functionally to influence others to align with new requirements
· Oversees implementation to ensure adherence to new requirements
· Set requirements for suppliers and monitor their compliance
· Oversee all product development procedures to identify deviations from quality standards
· Monitors spend and identifies additional project needs
· Evaluates Project Performance
· Ability to prioritize and handle multiple projects simultaneously
· Communicates and engages appropriately with vendors/suppliers
· Conducts sensitive conversations in a confidential manner with venders/suppliers
· Maintains sensitivity of communication with internal and external entities (e.g. stakeholders, venders, suppliers)
· Monitors progress by maintaining dialogue on work and results
· Makes good and timely decisions that keep the organization moving forward
· Strong execution skills
· Demonstrates agility and connectivity across the organization
· Actively builds connections and partnerships with others, internally and externally
· Ability to work with all levels of PD, supply chain, technology teams to build relationships across functions
Education and Experience
· University’s degree from an accredited institution in a related field
· Professional typically with over 8 years technical experience and a demonstrated track record
· Transitioning to Generalist in at least 1 area: Consumer products, medical device, food, dietary supplements or pharmaceutical
· Contributions focused on some strategic initiative as well as functional execution elements; starting to work independently and transition to people management
· May be consulted internally as an expert in the area of functional expertise
Skills and Competencies
· Practical understanding, interpretation, and application of ISO13485, MDSAP.
· Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates issues to internal and external stakeholders, including Senior Management.
· Ability to prioritize and to handle multiple projects simultaneously.
· Ability to work with all levels of management and to build relationships across disciplines.
· Excellent influence, persuasion, communication, and presentation skills
· Agile knowledge
· Involvement with remediation / process improvement projects
Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.
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