The Vice President of Compliance & Regulatory Affairs has overall responsibility for leading all aspects of regional regulatory affairs, and quality systems for the business. A high level description on responsibilities include managing all aspects of development and implementation of Regional Quality Management System, Healthcare Compliance and Regulatory Affairs Supply Chain strategies, frameworks, policies and priorities. This includes leading a team that would focus on standardizing business processes to ensure all activities are complied with GDP, GDPMDS, GMP, ISO, GHTF, EC, US FDA Standards & Regulations, Directives for Medical Devices, Pharmacopeia Standards, country regulations such as Singapore HSA (Health Science Authority, Singapore), Australia TGA, China CFDA Regulations, Compliance and Registration Requirements. Specific tasks include:

Responsibilities will include but not limited to:

 

  • Develop and deliver Regional Quality Plan Framework and Strategy

  • Identify and develop Regional Healthcare Warehouse Facility Standard Models and Validation Master Plan Standard Models

  • Identify and develop customized Quality Plan to handle individual customer’s requirements and their product handling requirements

  • Identify and develop Global eQMS (computerizing Quality Management Systems) framework, structure and processes

  • Manage, monitor and review regional QA/RA team’s services and performance target

  • Provide leadership, coaching and operational management to in-country Quality Managers to enable Supply Chain related activities are timely managed and compliant with Quality Standards and Regulations

  • Engage the various in-country Supply Chain Operations teams, QA/RA Teams and other key stakeholders as required for alignment to established QA/RA framework

  • Encourage and support the Quality Managers in promoting the ownership of quality within the region

  • Maintain an oversight of Quality system and processes against the agreed standards and expectations

  • Identify and develop Qualification and Certification program to close the staff competency gaps and regulations requirements

  • Identify and develop training plans for all staff as relevant and work with the aligned Regional Quality Systems improvement lead to co-ordinate and deliver training

  • Assist in the preparation for internal and external audits and resolution of any resultant findings through rigorous application of appropriate analytics tools

  • Ensure accurate resource planning and required skills mix and competencies are in place within the Regional Quality team

  • Responsibility & authority of this designation/position are linked to and in accordance with relevant and associated SOP

 

       SKILLS ESSENTIAL TO THE JOB

       Technical (Doing skills – job related knowledge, policies, procedures, techniques)

  • Must have strong knowledge of cGxP (such as Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), Good Storage Practice (GSP), Good Warehouse Practice (GWP) for Australia, Good Supply Practice (GSP) for China) and Quality Management Systems Requirements (such as ISO 9001 and ISO 13485)

  • Strong knowledge on Change Control, CAPA, Statistical Process Control, Training, Warehouse Quality requirements, Distribution and Manufacturing Process

  • Perform QMS audits at selected sites based on the company certification program

  • Hands-on, independent and self-motivated. Ability to lead, influence and work within cross-functional team environments

  • Good conceptual, analytical, problem solving, and organizational skills

       Business (Understanding of business concepts, knowledge of the organisation, profitability)

  • Communication style should be diplomatic and direct, but not confrontational

  • Must be able to articulate clear, tangible objectives for the organization, negotiate agreements where each party benefits, and can deliver an honest assessment of the level of achievement of those goals

  • Must work well in a collaborative team environment

  • Strategic and self-motivated with the ability to work and to achieve goals with a minimum of direction. Must be proactive in identifying issues and recommending solutions

  • A mature thinking and acting executive with good common sense and judgment, and a broad business perspective with outstanding administrative capabilities to build, motivate and manage a strong quality organization

  • Well-organized and accustomed to maintaining excellent records

       Human Relations (People skills in servicing, influencing, developing and leading others)

  • Pleasant personality, with good technical written ability and verbal communication in English and Mandarin

  • High level interpersonal and leadership skills with capability to influence, coach, and partner across multiple levels and locations of the company

  • Independent, reliable and aggressive in project management and time management

       ESSENTIAL PERSONAL ATTRIBUTES (Demonstrated in previous roles and the individual’s career track

       record)

  • Flexible and adaptable to changes

  • Sense of urgency

  • Organized, accurate and detail-oriented

  • Quick learner

  • Good attitude

  • Honesty and integrity

       QUALIFICATIONS REQUIRED


       Tertiary: 

  • Bachelor’s degree with a Master’s degree preferred, preferably in life sciences, engineering, or business

 

       Professional: 

  • QMS Professional Certificate.

  • Registered/Certified QMS Lead Auditor or QMS Auditor or QMS Internal Auditor or other appropriate equivalent

  • At least 10 years of Quality Management, Compliance and Regulatory Affairs related experience required

  • Min 10 years’ experience in a pharmaceutical GMP-regulated and/or medical devices industries

 

       Licences:

  • IRCA Certified QMS Lead Auditor

 

       Other:       

  • Experience in managing warehouse and Distribution Centre is preferred

  • Experience in GDP (Good Distribution Practice), GDPMDS (Good Distribution Practice for Medical Devices), GMP (Good Manufacturing Practice for Assembles of Medicinal Products), ISO 13485 environment is a must

VP, Compliance & regulatory affairs

Contact

Inmind Solutions Pte. Ltd.

7 Temasek Boulevard

Level 32, Suntec Tower 1

Singapore 038987

​​

Tel : 65 98636384

Email : Corporate@inmindsolutions.com

Website : www.inmindsolutions.com

Licence No : 17S8822

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