Senior Manager Commercial Quality

**Job Function**:
Quality
**Job Sub Function**:
Customer/Commercial Quality
**Job Category**:
People Leader
**All Job Posting Locations**:
Singapore, Singapore

The Senior Manager Commercial Quality is appointed as Management Representative and is accountable for the oversight and execution of effective Quality Management Systems and compliance at MD&D Medical Device AsiaPac (RDC) that receive, pick, pack, store, inspect, repack/relabel and deliver finished goods to J&J affiliates market in the AsiaPac, and customers, distributors, healthcare facilities in Singapore market

This role serves a single point of contact to Deliver operation lead on Distribution Quality related matters and liaise with multiple Quality organizations across regions and upstream quality pillars to drive timely resolution of Quality related issues.

This position optimizes quality systems and processes and ensures alignment with the APAC business, applicable regulations and J&J MedTech quality policies, strategic framework, quality vision, and provides a measurable impact to quality, cost, and customer value.

The position defines and implements departmental strategies and services as the business expert on quality systems, distribution, and quality management.

The position identifies opportunities to continuously improve quality, cost and time factors, consistent with business objectives. The position maintains understanding and awareness of current and emerging regulations and the impact to quality and distribution practices.

This individual plan, 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.

**KEY RESPONSIBILITIES**

**Quality Management Systems**
- Act as a management representative for the RDC QMS
- Accountable for management of Quality systems as per ISO13485:2016 and J&J enterprise and/or MedTech quality standards, integrating existing and new regulations to enable favorable compliance profile with applicable health authority in the region.
- Responsible for conducting Risk management of the warehousing, distribution and repack relabel processes, proactive identification and migration of compliance risk
- Ensure regulatory compliance and quality metrics are met; lead the development and implementation of actions to close metric gaps.
- Develop and establish quality policy and objective and ensure the achievement of quality goal and objective
- Sustain and culture of quality, helping business partners understand how they impact product quality, safety and regulatory compliance.

**Distribution and Inventory Management Processes**
- Accountable for overseeing the controls and quality standards for all distribution, value added service and inventory management activities.
- Responsible for robust product disposition procedures and the quality oversight of all product quality holds that impact on the RDC.

**Enabling Business Growth**
- Enable new product introduction and right stage customization and network optimization.
- Collaborate with deliver operation and supply chain end to end for reliable product supply
- Partner with deliver operation to ensure appropriate product supply metrics/targets are establishes, monitored and met.

**Supplier Management**
- Accountable for execution of Quality Agreements with 3rd party Logistics Providers
- Accountable for Quality oversight and Management of repacking, relabeling, over labeling, kitting, and reworking operations, loaner operation conducted in the 3PL DC
- Review supplier performance and establishes improvement plans to address below target metrics and negative trends.

**People Management**
- Responsible for carrying out managerial responsibilities in accordance with the organization's policies and applicable laws;
- Responsible for the overall direction, coordination, evaluation and talent development of the team members and to maintain and inclusive and high performing team..
- Execute performance management and succession planning processes per J&J /MedTech Policy.

**Qualification**:

- A minimum of a BS or BA Degree is required. An MBA or MS Degree is preferred
- This role requires a diverse business background and quality operation experience in regulated healthcare industry.
- 8-10 years of related experience in areas such as Quality Operations, Compliance, Quality Systems, Distribution Quality, business/commercial quality, in a highly regulated healthcare industry
- Experience in hosting external inspection
- Proven success in failure investigations, problem solving and issue remediation
- Influencing, negotiation and stakeholder management skills
- Excellent communication and interpersonal relation skills
- Analyzing / decision making ability