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Senior Manager Primary Container Lcm
il y a 1 mois
Janssen Supply Group, LLC., a member of Johnson & Johnson's Family of Companies, is recruiting for a **Senior Manager Primary Container Lifecycle Management **This role is within our Small Molecule Drug Product Primary Container & Device Team, Manufacturing Sciences & Technology. This position will be located at the Janssen Supply Chain (JSC) site in Beerse, Belgium.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
We, the Janssen Supply Group, LLC., are a part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as our primary focus, our group strives to provide access and affordability through innovation and strong collaboration with our R&D and Commercial partners to deliver life changing solutions for patients in need.
**Position Summary**:
The **Senior Manager Primary Container LCM **will provide technical leadership to a team of engineers responsible for the ongoing lifecycle management of primary container closure systems, dosing devices, and critical secondary packaging materials in the Janssen Supply Chain network. This team will take accountability for technical support including change control assessments, process improvements, complaint investigations, CAPA and audit support as required. The **Senior Manager **will be the key point of contact to site operations and quality leadership for their area of responsibility.
The Senior Manager will ensure all validation activities and ongoing production conducted at suppliers, external manufacturers and internal manufacturing sites are in compliance with all applicable procedures and to the requirements of 21 CFR Parts 3, 4,11, 210, 211 and 820 and Johnson & Johnson Policy Standards related to Good Manufacturing Practice (cGMP) for Combination Products, Pharmaceuticals, and Medical Devices.
**Key Responsibilities**:
- Provides technical leadership to a team of 1-4 engineers responsible for primary container closure systems lifecycle management activities
- Investigates suitability of use for the packaging materials and devices for pharmaceutical products including compatibility, protection, safety, processability, etc.
- Performs root cause investigations, leads improvement plans, and writes technical documents
- Leads changes according to the change control procedure, acts as change owner, assessor or action item owner
- Introduces new techniques to the solutions of problems and makes significant contributions to improve process efficiency and quality
- Partners with external suppliers and receiving sites to ensure component development processes lead to robust manufacturing processes
- Provides technical expertise to site personnel to adequately transfer the primary packaging material for design and technology transfer activities
- Supports manufacturing process capacity scale-up for internal and external manufacturing sites
- Delegates work assignments effectively, evaluates performance of employees, and plans developmental opportunities to increase efficiency, encourage job satisfaction and personal growth, and enhance professionalism.
**Qualifications**:
**Education**:
- Minimum of Bachelor’s in **Engineering **degree **required **; advanced degree or focused degree in Mechanical, Biomedical, or Materials Engineering is **preferred**
**Experience and Skills**:
**Required**:
- Minimum 12 years of relevant work experience
- Experience with glass, bottle and blister primary packaging materials, manufacturing and finishing
- Ability to interpret engineering drawings
- Ability to use statistical techniques when analyzing data and make rational and logical decisions based on that analysis
- Ability to balance multiple priorities and operate with poise and integrity in a sophisticated and constantly evolving environment
- Strong interpersonal communication skills and ability to collaborate with external suppliers, contract manufacturers, and global partners
- Proven compliance experience with one or more of the following is required: FDA CFR part 3, 4, 210, 211, 820, or ISO 13485 (e.g., Design Control, Change Control, CAPA, and Complaint Handling)
**Preferred**:
- Experience in leading global teams
- Experience with financial analysis and business case development
- Six-Sigma Certification
**Other**:
- Requires up to 10% domestic and international travel, including ability to work in an international environment across different time zones
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colo
