Sr. OpEx & PMO Manager-Quality Large Molecules, Aseptics

Job Description Summary

-Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures

Job Description

Key Responsibilities:

• Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review -Support OpEx improvement projects Qualified Person - Executes batch release in compliance with registration -Reporting of technical complaints / adverse events / special case sce
• Member of the Quality LMO Platform team, actively supports the Global Head Opex by contributing to the design and execution of the Quality Large Molecule Strategy
• Support the implementation of resulting actions of the LM Quality strategic long-term plan into the different LM Quality unit objectives
• Support to establish clear processes for tracking and managing the LM QA KPI s and yearly objectives for all units
• Track and manage Transformation initiatives across the Quality LM Platform
• Identify best practices across different LM Quality units internally and perform external benchmarks where appropriate. Based on those elaborate plans for productivity and operational improvements
• Support in ensuring monthly reporting for all LM Quality units
• Coordinate the preparation and set up the governance of major LM Quality management meetings
• Support the delivery of key global LM Quality projects
• Support the development and implementation of the LM Quality organization
• Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements.
• Manage communication and interface with internal and external stakeholders
• Support actively engage in and support global quality programs (including Quality Service Centers)
• Support in define and manage OpEx program and drive its implementation into all LM Quality units
• Support in drive OpEx Framework awareness culture, build OpEx capability and drive standardization across all LM Quality units
• Act as a strong business partner across Global, Platform and Site teams as one hand and all enabling functions at the other hand.

Essential Requirements:

• Technical and/or business school educated with strong background in project management and change management
• 10+ years of overall experience (manufacturing/operations management experience) of this, >5 years within similar role and complexity; experience in Health Care / Pharma Industry preferred
• Certified Lean / Six Sigma Certification (Green belt) from an institute of repute
• Strong leadership capabilities (decision making, result oriented, challenge capability, negotiation, supporting others, stakeholder mgt, change mgt, leading in a matrix organization)
• High performing, credible professional, with a track record of successfully leading strategic and global / cross functional projects and teams.
• Cultural awareness and sensitivity; ability to network and communicate with all levels of the organization.
• The incumbent requires organizational capabilities and a high level of diplomacy.
• Strong analytical skills, focused with business awareness and hands on; Very good communication and organizational skills
• Team worker and energetic, can-do attitude; Change Agent skills
  

Desired Requirements:

• Technical and/or Business Degree level (minimum)

Skills Desired

Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Gmp Procedures, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence