QA Integration Lead Job

Job description

QA Integration Lead-9082151001DescriptionJohnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Integration Lead, based in Fort Washington, PA.Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.
Working with the Site Quality leaders the QA Integration Lead oversees the plans, coordinates, and oversees the implementation of commercialization activities and integration of improvement projects in the Quality organization (Including the laboratories). These activities include managing the on-boarding of all QC Analytical and Micro testing methods, managing the integration of tech transfer testing methods into the labs, and identifying and implementing projects to gain efficiencies in other Quality Systems. The position is designed to ensure streamlined start-up and transition to commercialization of products consistent with established standards by performing the following duties personally or through collaboration with department members.
QA Integration Lead will coordinate with Planning and Tech Ops to manage/integrate future Tech Transfer activities in Quality. Acts as advisor to Quality Management to help meet established schedules or resolve technical or operational problems as part of the product projects. Reviews report findings and works with the team to develop recommendations of corrective actions. Challenge existing systems to seek more efficient, more compliant performance and implement whenever possible. Provide reports and feedback to inform management of trends or inefficiencies and to establish corrective actions. Maintain knowledge of regulatory environment, cGMPs, CRF Part 210 and 211, FDA policies and current industry trends. Actively support QA and Site leadership to assure compliance with quality, environmental and safety regulations as well as company policies. They will be accountable for achieving the targeted project key performance indicators. Liaise with the other Cross Functional Operations and QA Management at McNeil Healthcare sites and other plants to identify best practices. This position demonstrates considerable knowledge/expertise in leading supply chain projects (preferably pharmaceutical). They will apply Process Excellence methodologies and tools to effectively and efficiently manage projects. They will manage competing project constraints: scope, quality, risk, time, cost to meet schedule and financial commitments. Leads core team through regular core team meetings capturing and communicating decisions and action items.
All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.
QualificationsBachelor's Degree in Technical, Science, Business Administration or related discipline is required. A minimum of 6 years of experience in a Pharmaceutical, and/or Consumer industry environment is required, preferably in Quality or Supply Chain. Experience with documentation and technical writing skills, in a regulated compliance environment, is preferred. Strong influencing, negotiations, and leading without direct line authority experience is required. The ability to manage complexity, manage a diverse team, and effectively negotiate/influence upper management is required. The selected individual must demonstrate proven critical thinking, people & team development, strategic aptitude, independent leadership, ability to interact with Regulatory Authorities, collaboration, and training ability is required. Excellent written and oral communication and interpersonal relationship skills across all levels are required. Knowledge of FDA CFR 210 and 211 Regulations is required. A strong experience in Project Management is required. This candidate will be based in Fort Washington, PA and will be required to travel up to 10%BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NAPrimary Location:North America-United States-Pennsylvania-Fort WashingtonOrganization: J & J Consumer Inc. (6101)Job Function: Quality (Eng)Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement