Johnson & Johnson Consumer, Inc. is recruiting for a Senior Manager, Regional Laboratory COE, to be located in the United States, Canada, or Puerto Rico.
Johnson & Johnson Consumer Inc., based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S Baby, BAND-AID, NEUTROGENA, TYLENOL, MOTRIN, and LISTERINE. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.
Are you passionate about improving the health of other humans?
This is an exciting and growth potential role! You will work closely and in conjunction with the Regional Head of Q&C.; In this role, you will provide the framework for execution of strategies and the oversight of implementation tactics. Your scope will include key systems, processes and investments, supporting internal and external Plants. You will act as a chief of staff to the Regional Quality and Compliance lead. You will also become single point of contact across the regional portfolio of all activities of 3 pillars of Quality; namely Quality System, Labs and Quality Excellence. You will represent the voice of the Region in many related governance forums. These include base business execution, strategic support and compliance focus.
Key Responsibilities:
In conjunction with the Regional Head of Q&C;, this role leads the framework and strategies of the Analytical Chemistry and Microbiology Laboratories and Marketed Product Stability Program. This role collaborates with the team of Laboratory Quality leaders/professional to actively aid in executing the development of regional strategies, tactics and programs related to Laboratory initiatives to achieve short-term and medium range goals.
This role monitors and actions around regional laboratory performance to ensure that the efficiencies and quality meets J&J; and Regulatory standards.
* Base Business: Lead the harmonization and standardization of Laboratory processes and maximize standard methodologies within the region and across the globe. Partners with MAKE and MAKE Excellence in support of Financial, Service and Quality Lab critical metrics.
* Strategic Support: Based on global initiatives, provide strategic support for continuous improvement initiatives, programs, processes and governances with the region. Partner with Finance and E2E functions ensuring strategic investments in the region are aligned to LCM of equipment and in tandem with MAKE Q&C; Strategic Plan.
* Compliance: Act as liaison between the Plants' Laboratories (Internal, External and Contract Labs) and Regulatory Compliance on Inspection Readiness, GMP, Micro and JJRC audits as well as 3rd party audits and management action plans, including gaps closures identified.
Qualifications
Education:
* A minimum of a Bachelors degree (or University equivalent) in science, engineering or related field is required. An advanced degree or a degree in Microbiology, Biology, Chemistry, Chemical Engineering or related subject area is preferred.
Required:
* A minimum of 8 years of Pharmaceutical/OTC and/or Cosmetic experience required with a demonstrated ability in a leadership role of QC in MAKE Quality and/or Compliance in a regulated QA environment is required
* Knowledge of FDA Regulations, specifically 21 CFR 210 and 211, and experience in QMS related to inventory release/control/MRP/DRP systems, SAP is required
* Prior experience in Supervision and management of professionals in a QA or QC Lab, with broad-based experience or combination of experience, in pharmaceutical manufacturing, Quality Operations, Regulatory Compliance or Regulatory Affairs functions is required
* Experience working at a regional level and in matrix organizations and global interactions or global projects with cross functional collaboration, highly desirable is required
* Change-management experience and be a proven change agent as to DELIVER in a highly agile and complex environment is required
* Strong influencing and demonstrated teamwork experience required
* Excellent written and verbal communication and people and project management skills is required
* Chemistry or Microbiology knowledge required
* Worked and flourished in a matrix environment. This includes working in and with complexity, ambiguity, influencing without authority, and operating effectively in teams and squads. Able to manage stakeholders at global and Asia Pacific levels is required
* Energetic, with strong interpersonal, organizational and communication skills, Self-motivated.
* Strong organizational skills & must be able to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile, and rapidly changing environment.
Preferred:
* Project Management experience and knowledge of Process Excellence tools such as FPX, is highly preferred.
* Ability to define problems, collect data, establish facts and draw valid conclusions is preferred
* Data driven foundational skills including able to extract insights when evaluating complex data to put forth recommendations to improve the business at hand are preferred
* Working knowledge of global complaint handling processes is preferred.
Other:
* This position will be located in the United States, Canada, or Puerto Rico and may require up to 30% domestic and international travel
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location
United States-New Jersey-Skillman-
Other Locations
United States, Canada, United States-Puerto Rico
Organization
Johnson & Johnson Consumer Inc. (6101)
Job Function
Quality
Requisition ID
8888200723
New Brunswick, New Jersey
Johnson & Johnson, together with its subsidiaries, researches and develops, manufactures, and sells various products in the health care field worldwide. It operates in three segments: Consumer, Pharmaceutical, and Medical Devices. The Consumer segment offers baby care products under the JOHNSON’S brand; oral care products under the LISTERINE brand; beauty products under the AVEENO, CLEAN & CLEAR, DABAO, JOHNSON’S Adult, LE PETITE MARSEILLAIS, NEUTROGENA, and OGX brands; over-the-counter medicines, including acetaminophen products under the TYLENOL brand; cold, flu, and allergy products under the SUDAFED brand; allergy products under the BENADRYL and ZYRTEC brands; ibuprofen products under the MOTRIN IB brand; and acid reflux products under the PEPCID brand. This segment also provides women’s health products, such as sanitary pads and tampons under the STAYFREE, CAREFREE, and o.b. brands; wound care products comprising adhesive bandages under the BAND-AID brand; and first aid products under the NEOSPORIN brand.
The Pharmaceutical segment offers products in various therapeutic areas, including immunology, infectious diseases, neuroscience, oncology, pulmonary hypertension, and cardiovascular and metabolic diseases. The Medical Devices segment provides orthopedic products; general surgery, biosurgical, endomechanical, and energy products; electrophysiology products to treat cardiovascular diseases; sterilization and disinfection products to reduce surgical infection; diabetes care products; and vision care products, such as disposable contact lenses and ophthalmic products related to cataract and laser refractive surgery.
The company markets its products to general public, and retail outlets and distributors, as well as distributes directly to wholesalers, hospitals, and health care professionals for prescription use. It has research and collaboration alliance with Morphic Therapeutic. The company was incorporated in 1887 and is based in New Brunswick, New Jersey.