Manager Manufacturing
Il y a 7 mois
This position reports to the Head, Technology Compliance.
**Approximate Percentage of Time**:
**Tasks/Duties/Responsibilities**
60%
**Risk-Based Closed Loop Supplier Audit and Periodic Review Programs**:
- Leads and executes closed loop periodic reviews of J&J Segment (Pharm, Med Tech and Enterprise) GxP computerized systems that are supported by Technology Quality including a large global portfolio of computerized systems covering Manufacturing and Laboratory.
- Leads and executes closed loop technology supplier audits, covering GxP related software and technology service providers, including suppliers of infrastructure as a service (IaaS), Platform as a service (PaaS), Software as a Service (SaaS).
- Provides compliance SME inputs to TRC risk assessment process to ensure complex risk factors associated technology are incorporated into the framework, executing on audit commitments and prioritizing processes as necessary to adjust schedule. Identify risks in current processes through data driven decision making and solutioning.
- Determines and documents adherence to Johnson & Johnson enterprise standard operating procedures and regulatory requirements and identifies and communicates compliance related issues, including the risk criticality of each issue; the validated status of systems; and the rating/classification of suppliers.
- Identifies and communicates potential quality and compliance risks, articulates impact, and gains alignment from business partners to establish proactive risk mitigation strategies.
- Authors audit reports and documents observations and commitments clearly, accurately and timely to enable tracking verification.
- Utilizes expert knowledge of regulations and risk management concepts to ensure compliance with local and global regulations.
- Reviews remediation action plans for acceptability and leads and executes audit follow-up activities to verify effectiveness of audit corrective action plans.
- Partners with other compliance groups (J&J Regulatory Compliance/ R&D Compliance/ Global Audit & Assurance) as needed on for auditing and remediation activities.
- Applies knowledge of current and emerging regulatory trends to continuously improve audit programs.
- When applicable, leads and/or supports the delivery of education and training on compliance requirements, procedures and controls.
40%
**Stakeholder Management, Compliance Expertise and Support for Base Business and Innovation Initiatives**
- Provides regulatory compliance expertise and support to business partners in support of business innovation initiatives and serves in a compliance strategy advisory capacity in the development of compliant pathways that meet regulatory requirements specific to business area under their E2E accountability
- Maintain up-to-date and emerging knowledge of compliance processes and changes (real-time occurring or imminent).
- Implements a relationship management plan to maintain consistent touchpoints with process area stakeholders, business owners, and TQ&C leads.
- Maintains trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives and helps others to do the same.
- Maintains knowledge of strategic digital initiatives and major innovation programs across J&J globally and serves in a compliance strategy advisory capacity in the development of compliant pathways that meet regulatory requirements specific to business area under their E2E accountability
- Serves as a trusted partner across the Global Technology Quality & Compliance organization and directly manages relationships with relevant TQ systems and infrastructure assurance (S&IA) sub-pillar.
- Participates in gap assessments to new or evolving regulatory requirements and guidances.
- Participates in industry and other professional networks to ensure awareness of industry standards, trends and best practices in order to strengthen GxP audit knowledge.
**100%**
**Total**:
- Develops and maintain an effective working partnership with senior management.
- Mentors talent and helps them grow in their careers.
- Collaborates with other leaders and staff within Technology Quality & Compliance to ensure each function is executed in an efficient manner.
- Ensures timely reports of status, metrics and time sheets as required by the Technology Quality & Compliance organization
- Assists with the timely reporting of status and metrics as required by the Technology Regulatory Compliance organization.
- Ensures timely completion of assigned training.
**Qualifications**:
**Basic Qualifications**:
**Required Years of Working Experience: 3-5**
**Required Knowledge, Skills and Abilities**:
- A minimum of a Bachelor’s degree is required. Advanced degree preferred.
- A minimum of 3-5 years of related experience is required.
- Experience in the pharmaceutical/ medical device/ biotech industry is required.
- A minimum of 2 or more years leading and executing audit
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