Sr Commercial Quality Manager NA - Parsippany, NJ
Sr Commercial Quality Manager NA - Parsippany, NJ, US, 07054 We are Reckitt
Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege. Research & Development In Research and Development we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance. We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality. The size of our organisation means you'll have the opportunity to learn and work in different functions within Research and Development, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation. About the role Provide leadership for excellence in Quality and Compliance of Core Reckitt products and processes within the Commercial Organizations in North America - this including the distribution and embellishment of finished products, custom manufacturing organizations, R&D projects validation and Consumer Relations.This position is responsible for ensuring that the commercial organizations in NA maintain compliance with applicable regulations as appropriate while also supporting and enabling the business to achieve its business objectives. The Sr. Commercial Quality Manager must work effectively with internal parties, manufacturing sites, third parties, external bodies and corporate personnel. Your responsibilities
- Provide the overall leadership in the areas of quality management systems, documentation control, and quality control, both internally and external - with business units, distribution centers, and embellishers. This includes assuring that all product specifications and all regulatory requirements have been satisfied prior to the final release of any product into the distribution channel.
- Provide leadership to the commercial quality organization that has the final responsibility for the compliance and distribution of any product by Reckitt North America. Release criteria must be constantly reviewed with internal stakeholders (manufacturing sites) and externally with external manufacturers; to ensure the overall compliance to internal and external quality requirements during the receipt, storage, distribution, manufacturing, packaging, and testing of the final product.
- Quality oversight of freight operations, DCs and embellishers in NA, including the DCs & embellishers shared with Health Business Unit.
- Quality oversight of R&D projects risk assessment, validation and implementation with manufacturing sites - specific coordination with internal manufacturing sites and lead the implementation with external manufacturing sites
- Relentless obsession with quality on shelf and consumers experience - lead intelligent evaluation, interpretation of consumer care data and trending, and promote actionable remediation & prevention tasks.
- Assure that all complaints and inquiries involving product quality are thoroughly investigated, examined for trends, reported to senior management, and effectively addressed by corrective and preventive actions as deemed appropriate.
- Coordination of resolution of any quality, compliance and safety issues affecting products in market
- In conjunction with the Quality Director for NA, responsible for developing and deploying the Quality strategic plan and assuring the integration/alignment into Commercial Quality strategy.
- Interfaces with commercial General Managers in the region in areas of quality decisions, such as escalations, field actions and or other significant quality issues.
- Act as the primary interface with international, federal, state and local regulatory officials in regards to the storage and distribution of any drug products, medical devices, food products, dietary supplements, general products, and biocides as the audit host in the Logistics Centers.
- Interpret GMP regulatory requirements and provide guidance for effective compliance, as well as providing support for programs and projects, especially those requiring GMP compliance.
- Ensure Quality Management Systems supporting commercial organizations in NA are in constant state of readiness for planned and ad hoc regulatory audits or inspections.
- Ability to effectively lead teams located across US and Canada regions.
- At least 10 years of work experience in manufacturing and or distribution of pharmaceutical products, medical devices or food industry in a professional / exempt level position in the areas of Quality Control, Quality Assurance, Quality Compliance, or similar disciplines.
- Sound understanding of GMP's and regulations especially for importing and distributing of Health, Food, or Hygiene products.
- Demonstrated ability to act in a leadership capacity developing and implementing business / quality processes and strategies, leading managerial and professional technical personnel, and coordinating the execution of multiple complex projects in a fast-paced CPG environment.
- Must have a strong working knowledge of and significant leadership / managerial responsibility for quality systems in development and manufacturing in the consumer goods, pharmaceutical, or medical device industries.
- Must have experience with quality tools such as: SPC, Advanced Quality Planning, Control Plans, CAPA, change control, FMEA, Root-Cause Analysis, Six Sigma, cross-functional problem-solving teams, etc.
- Ability to deal confidently and effectively with agents of governmental regulatory bodies as well as internal and external customers and suppliers.
- Must exhibit excellent communication and facilitation skills, both oral and written.
- Experience effectively leading and growing people managers, setting direction, providing development feedback, and managing performance.
- Bachelor's degree in a scientific or technical field such as Chemistry, Chemical Engineering, Industrial Engineering, Mechanical Engineering, Manufacturing Engineering or similar.
Nearest Secondary Market: Newark
Job Segment: Medical Device, Counseling, Nutrition, Healthcare
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