Manager, External Quality Customer Complaints

Johnson & Johnson Family of Companies is currently hiring for a Janssen Supply Chain, Manager, External Quality Customer Complaints. This position can be located in Horsham, PA, Raritan, or Titusville, NJ and Latina, Italy. Other locations within the US may also be considered. Remote work may be considered on a case-by-case basis and if approved by the business.
- Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need. _

THE MANAGER, EXTERNAL QUALITY CUSTOMER COMPLAINTS IS EXPECTED TO:
The Manager, External Quality Customer Complaints is accountable for completion of product quality complaint manufacturing investigations related to products manufactured by Janssen external partners.
- Represents EQ on various workstreams and teams working on the Janssen complaint process.
- Interacts closely on a global basis with EQ Account Managers, PQV, PQM, CQ, and Quality Assurance functions at internal Janssen Supply Chain sites. Also interacts with individuals in other J&J segments and at all levels in procurement, quality, supply chain and technical groups across the Operating Companies.
- Establishes one common complaint process for External Quality.
- Possesses knowledge of cGMPs, regulations and risk management requirements to allow for independent administration of product quality complaints in order to execute a thorough complaint assessment in accordance with Standard Operating Procedures while utilizing the Quality Complaint Handling System. This may include, but is not limited to, review of the event reported, criticality assessment, decision-making, communication with third parties, follow-up, assessment of investigation findings, evaluation of field samples, and ensuring timely escalation to management when applicable.
- Leads a team of up to 10 people.
- Works independently, challenges the status quo, identifies gaps and process improvements. Participates within special projects as needed.

**Key Responsibilities**:

- Process and analyze product complaints according to Policies and Standard Operating Procedures.
- Manage Product Quality Complaints to ensure standard process is followed, and data is consistent and of high quality, to assist with correct decision making.
- Evaluate product quality complaints for seriousness, correctness, and consistency of categorization.
- Communicate with External Business Partners to ensure timeliness and review their investigation report for accuracy and completeness.
- Partner with stakeholders (JJQS, PQV, Internal JSC Manufacturing Sites, External Business Partners, Regional External Quality organizations, Call Intake Centers, Global Medical Safety/LSOs, Marketing, Sales Administration, Brand Protection, etc.) to gain knowledge of products and processes.
- Develop and generate reports associated with the Quality Complaint Handling System and associated processes.
- Manage complaint field sample process, as applicable.
- Support internal and external audits and inspections.
- Participate within special projects.
- Attend Monthly meeting/ trainings/ calls.
- Develop and update complaint handling procedures.
- Provide training and mentoring to new employees.
- Manage a highly functioning team of associates that are responsible for the day-to-day processing of product quality complaint investigations on behalf of the External Quality organization

**Qualifications** Education**:
A minimum of a Bachelor’s or equivalent University degree is required, with a focus in a scientific discipline preferred. MA/MBA or Advanced degree is desirable.

**Experience & Skills**:
**Required**:

- A minimum of 8 years relevant work experience
- 2+ years of experience in quality management, production, quality control, or R&D in a pharmaceutical and/or biotechnology environment with experience in manufacturing operations or Quality Assurance.
- Ability to handle a high workload and deliver to negotiated deadlines

**Preferred**:

- Experience in external manufacturing
- Direct working knowledge of the business environment outside of the quality organization (e.g., manufacturing, product / process development, etc.)
- Prior people management experience
- Demonstrated knowledge of manufacturing processes, complaint vigilance global regulatory requirements, including 21CFR parts 210 and 211, ICH Q10 and CFR 820.198
- Understanding of Quality and Supply Chain processes & organizational structure

**Other**:

- Strong independent partnering and interpersonal communication skills.
- Ability to work independently in a global environment/virtual team as an individual contributor, team member, and team leader.
- Ability to build and nurture strong, positive relationships with bu