Nordics MD Quality Head

Modis Life Science is recruiting for a consulting assignment at a pharmaceutical company in Solna. The assignment is initially for 7 months.

The position plans, coordinates, and directs quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through subordinates.

Essential duties and responsibilities:
Distribution and Inventory Management Processes
Responsible for execution and overseeing the controls and quality standards for all distribution and inventory management activities
Responsible for robust product disposition procedures and the quality oversight of all product quality holds and field actions impacting the Distribution Centers.
Responsible for evaluating the company´s quality and distribution process capabilities against company and industry standards and regulatory expectations.
Special Processes (Product Testing, Repack-Relabel, Temp. Control & Monitoring)
Accountable for defining and implementing requirements for physical product testing (e.g. functional testing, visual inspection & verification) occurring in the DCs or outsourced by the DCs.
Responsible for defining, designing and implementing requirements for repackaging and relabeling operations to be conducted within the Distribution Center to assess repackaging and relabeling requests and collaborate with business partners to meet pre-defined requirements.
Accountable for Quality management of repacking, relabeling, over labeling, kitting, and reworking operations conducted within the DC (as applicable)
Accountable for adherence to temperature control and monitoring requirements within the facilities.
Accountable for validation of temperature controlled (cold chain and controlled ambient) facilities with support and directions from the Sr. Manager Transportation and Temperature Control Q&C, DELIVER Q&C EMEA.
Accountable for accurate and timely communication of temperature control excursions occurring within the DC to appropriate partner.
Accountable for the investigation of temperature control excursions and subsequent remediation activities.
Quality Management Systems
Responsible for ensuring the appropriate handling of distribution related customer complaints including track and trend and mitigation of Quality related issues.
Responsible for overseeing the controls and quality standards for Quality Systems validation, including WMS, CAPA, NC, Internal Audits, Document Management software systems.
Accountable for management of Quality systems, including CAPA process and systems, document management, change control, training management, preventative maintenance systems, Quality agreements, other.

Compliance
Responsible for management of Management Reviews of the DCs.
Responsible for the successful management of all Health Authority inspections (e.g., FDA, MHRA, etc.) as well as other logistics and transportation related inspections (e.g., TSA, DEA, etc.) conducted.
Responsible for the proactive identification and mitigation of compliance risk at the DCs through Curve standard tracking system, internal audits, and other compliance programs.
Accountable and responsible for timely and accurate metrics and reports per J&J policies. Reporting responsibilities within the corresponding cluster include (but are not limited to):
- Metric evaluation and reporting in PRISM.
- CURVE entry updates.
- Execution of Distribution Center Management Reviews.
Responsible and accountable for the management of facility licenses. (if applicable)
Support departmental goals and objectives, and business measurements.
Distribution Supplier Quality Management
Supports for establishing Quality Agreements with, qualifying of, and Q&C management of distribution, logistics, and material suppliers (excluding Distributors).

Country Specific Responsibilities
Responsible for actively providing Quality input and oversight on distribution network changes.
Responsible for calibration and internal audit programs, supplier management, Quality event management, distribution complaint handling
Managing Equipment and software validation.
Responsible for document management
Support Loan kit operations and supply chain on site
Responsible for training program on site
Responsible to provide Metrics for the reporting period

Job Requirements
Essential knowledge and skills:
This role requires a diverse business background, with specific quality, regulatory and regulatory compliance competencies in the areas of: customer service, distribution and commercial customer interface. Experience in positions of increasing responsibility, with broadly based quality management experience. Experience with the global demands of the role specifically: healthcare regulatory requirements.
Proven success in:
• DC Q&C management.
• Understanding the linkages in quality and regulatory compliance in delivery to customer and health authority.
• Compliance experience, QMS experience.
• Change management and project management experience.
• Strong presentation skills.
• Issue remediation experience.
• Collaborative approach.
• Managing complexity.
• Analytical skills with a Bifocal approach - ability to zoom-in/zoom-out for tactical, high-level and detailed, etc.
• Previous experience interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc, and a history of success and credibility resolving complex regulatory compliance issues.

Education

Degree in engineering, scientific, business or QRC discipline

Core competencies required for this role:
• Organized, and able to work effectively with people within a complex social, cultural and political environment.
• Must have excellent communication skills, able to inspire trust and quickly build credibility within the Quality & Compliance, Supply Chain, and Commercial organizations.
• Must have strong collaboration and influence management skills to partner effectively across functions and operating units.
• "hands-on" operational orientation.
• Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results. Recognizes and builds support for change. Engages in constructive conflict.
• Ability to fit in well culturally in a complex organization.