Job Description:

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).

• Belgium (Beerse) Req #: R-047934
• USA (Raritan, Titusville) Req #: R-046243
• Switzerland (Schaffhausen) Req #: R-047927
• Italy (Latina) Req #: R-047934

We may also consider qualified internal candidates located in other Innovative Medicine manufacturing sites.

POSITION SUMMARY

The Senior Director PQM Strategy Deployment & Excellence is part of the Product Quality Management organization and will drive Product Quality (PQ) Excellence leadership, He/she is responsible for the development, deployment and execution of the strategy and roadmap for Product Quality Management & alignment with the major business partners in Innovative Medicine (IM) Supply Chain, IM Quality and DPDS. The individual also provides functional management to PQM Stability CoE, Risk Management and PQM Support, Central Product Complaint Investigation and PQM Digital Excellence

The Senior Director PQM Strategy Deployment and Excellence is a member of the PQM Leadership Team.

KEY RESPONSIBILITIES

• Under the direction of the Vice President, Product Quality Management, provide Product Quality Excellence leadership to PQM and global initiatives across IM Quality and Supply Chain.
• Owns the development and deployment of the PQM Strategy, ensure alignment of the Strategy and execution with IM Quality and other key PQM business partners such as Value Chain Management, Discovery Product Development and Supply (DPDS), Clinical Supply Chain and Small Molecule / BioTherapeutics development teams and within the IM Quality verticals,
• Owns the PQM elements for IM Quality
• Owns PQM Stability Program Management CoE. Ensure compliance with all regulatory and IM and JnJ requirements while maximizing efficiency.
• Lead IM Stability Program Management (SPM) cross functional team to ensure IM SPM strategy is established and updated, SPM performance measures are in place and continuously improving through effective cross functional team collaboration.
• Owns Quality system elements including but not limited to the Quality Management review process, internal audit, documentation management, training, etc. within PQM to ensure compliance and continuous improvements.
• Direct Product Risk Management activities within IM to ensure compliance with regulatory requirements. Ensure the successful application of Product Risk Management tools such as Criticality analysis, Product Risk Analysis (PRA)/Product Risk Management (PRM), FMEA, etc. within IM.
• Leads the initiative to develop and promote more data driven and innovative approaches within the PQM team. Supports PQM through better product analytics, dashboards and continuous improvement projects. Holds accountabilities for all activities performed within the PQM organization. Act as a representative for PQM at IM Quality and other global digital forums and initiatives.
• Responsible for core PQM business processes such as PQM LRFP, Budget, Cascade, etc. Together with the team identifies, quantifies and drives improvement opportunities within PQM.
• Build organizational capability and ensure his/her group effectively executing JnJ’s performance management and talent development processes; having adequate resources and expertise to perform their duties related to product quality. Plan and manage the groups budgets.
• Remains current in knowledge, skills and industry trends. Contributes to the strategy setting of the entire PQM organization. Train in new regulations, guidelines, procedures and processes. Make a positive contribution by making suggestions for improvement.
• Deliver portfolio of projects including product or therapeutic area projects flawlessly using proven project management tools.

Qualifications

• A Bachelor’s degree in Pharmaceuticals, Chemistry, Engineering, Sciences or similar
• An advanced degree and/or Business (MBA, MS or PhD) is preferred.
• At least 15 years of senior level experience in Biotech/Pharmaceutical Medical Device/ Industry and broad scientific expertise, having demonstrable experience in leading complex global programs and improvement initiatives, projects and groups of professionals are required. Multifunctional background preferred.
• A minimum of 7 years of people management & talent development experience is required.
• Must have strong leadership skills and operate as a leader with global mindset, understanding and appreciation of the global /enterprise context.
• Relationship management, excellent coaching and collaboration skills are required.
• Must be an analytical and strategic thinker with the ability to create integrated sector wide solutions to align with sector and enterprise requirements.
• Influence, shaping solutions, negotiation and consultative skills are required.
• Must be a thought leader experienced in shaping solutions, with strong communication and collaboration/partnership skills.

Required Skills:

Preferred Skills: