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We are searching for the best talent for Quality Manager – External Manufacturing to be in Sao Jose dos Campos, Brazil
Purpose:
The position is highly independent and accountable for the oversight and execution of the quality and compliance requirements applied to the management of the J&J Innovative Medicines External Manufacturers (EMs) in LATAM as well as to the Partnership for Product Development (PDPs) Projects in Brazil. As EMs partners, the manager will work with key stakeholders and JSC internal sites to guarantee: Selection & Qualification of EM sites, Operational Quality Oversight, Risk Based Approach to Quality Management, End to End Product Lifecycle Management, Batch release of high-Quality product for patient supply. As PDPs projects EQ lead, will work with key Government Officials and internal stakeholders to guarantee the Small or Large Molecule Tech Transfer projects are carried out in accordance with Brazilian PDP Regulation, c GMP, Regulatory requirements, Health Care Compliance (HCC) and J&J applicable Product quality standards
You will be responsible for:

• Perform applicable External Partners End-to-End Quality Management Processes: Selection & Qualification, Development/Negotiation of Quality Agreements, Technical transfer and process validation support, Ongoing Risk-based supplier evaluation, Risk Remediation, Monitoring activities including auditing and on-site technical assessments, Quality Review Meetings.
• Partner with key stakeholders and core team members to define the Quality Strategy for the PDPs projects, as well as accomplish all quality deliverables pertaining to each applicable step of the End-to-End Tech Transfer project, such as Secondary and Primary Packaging, Drug Product and Drug Substance manufacturing, Analytical Method Transfers and Master/Working Cell banks. Influence PDP Partners to perceive the value and implement J&J Product standards even dough not mandatory for local Regulatory Requirements;
• Perform quality processes in a timely and robust manner such as Change Control, Non-conformance/CAPA Management, Risk Management, Record Management, Development/Review/Approval of Standard Operational Procedures, Inspection Management, Complaint Management, Product Quality Review
• Proactively and systematically monitor and identify potential quality risks. Communicated and escalated identified risk in a timely way.Build relationships with internal and external partners and influence to continuously enhance quality culture and business excellence, while serving as open-minded Quality partnership facilitator.
• Evaluate changes proposed by PDP Partners and make sure they are equivalent compared yo IM process design and avoid differentiation on process and product profile what is not allowed by PDP rules .
• Support alignment with c GMP and J&J standards and complete gap assessments in close collaboration with internal and external partners
• Develop strong relationship with PDP Partners and EM in order to be perceived as a value-added Partner. Provides risk-based Q&C direction, perspective, and support to EQ PDP Projects dedicated resources
• Create and develop SOPs and training documentation
• Represent Latam in the applicable Global forums, initiatives and Community of Practices
• Assit with regulatory inspections and provides follow up on regulatory commitments
• Interact with Health Authorities

Qualifications

• A minimum of a bachelor’s degree is required. A focused degree in a Pharmacy, Biosciences or Engineer related disciplines is preferred. An advanced degree (Post Graduation, Master’s/MBA) is preferred.
• Minimum of 8-10 years in Quality & Compliance functions in highly regulated products industries is required; preferably in a pharmaceutical / biologics manufacturing or quality environment
• Fluent in English and Spanish
• Experience to develop Quality Systems and provide c GMP compliance support to External partners is required.
• Ability to provide c GMP compliance support to external partners by investigating and resolving quality issues is required.
• Experience with Technology Transfers is required.
• Demonstrated experience with all dosage forms is preferred.
• Experience with Large Molecule/Biologic products is a differential.
• Principles of Aseptic Processing is preferred.
• Intellectual curiosity and proactivity to continued develop/enhance knowledge in different product platforms and manufacturing processes as needed in order to perform job duties with robustness.
• Lead by influence and shape a good work environment – with internal and external partners/areas.
• Strong communication skills both written and verbal.
• Critical and analytical thinking ability.
• Self-awareness and adaptability.
• Problem solving and decision-making skills.
• Global Leadership areas: Integrity and Credo Based Actions, Sense of Urgency, Results and Performance Driven,
• Collaboration , Business acumen and Quality Risk Management.
• Proficiency in computer applications such as the MS Office.