APAC Life Sciences Quality and Compliance Director

APAC Life Sciences Quality and Compliance Director

What this job involves:

Strategy and Development

Overall responsibility for regional QRC activities across the Work Dynamics Life Sciences business within the region. Ensure that QRC strategies and processes are in place to meet business objectives, regulatory cGxP compliance, and operational needs in terms of price, quality and delivery targets and which enables the company to function and compete effectively in the market and in a sustained manner. Evaluate the risks faced by the business and take action to mitigate and develop opportunities. Contribute to overall business strategy for Quality, Risk Management and Business Assurance to ensure Work Dynamics has a consistent approach that is steeped in ISO and TQM.

Accountable for alignment of all Life Sciences account quality programs within the region, and ensures regional connectivity with their peers in other regions and with global Life Sciences quality, risk and compliance systems. Ensures training and compliance is defined and undertaken by account level teams, and quality programs are defined and established by account teams to full adherence to GxP requirements. Ensures overall organizational compliance and effectiveness by providing QRC leadership for the regional Life Sciences business, and ensures that the operations team manages service delivery in agreement with JLL processes and regulatory expectations. Working with the regional Life Sciences leadership, the position also contributes to the development and implementation of organizational strategies, policies and practices. Serves as a collaborative supporter and member of regional or vertical quality and compliance team, with the responsibility to develop and share best practice processes that enable world class operational service delivery across multiple client portfolios and potential new customers.

Responsibilities

• Coordinate use of the JLL quality management systems (QMS) across Life Sciences industries and clients within the region, and optimize the use of the JLL QMS to add value and minimize compliance risk for integrated facility management (IFM) services provided to our clients.
• Create and implement best practice quality vision, strategy, policies, processes and procedures to aid and improve business performance.
• Drive any necessary culture change and improvement in business performance to deliver strategic goals.
• Establish quality and reliability standards by studying regulatory compliance expectations, industry benchmarks, and customer requirements.
• Define appropriate metrics required to assess operational compliance performance against standards. Provide performance reports on status of Life Science account compliance against QMS requirements and regulatory expectations.
• Implement new QRC processes and systems where appropriate in alignment to changes in global standards (including ICH Q9 and Q10, ISO 9001 and 13485, MDSAP, and local regulatory requirements defined by TGA, PDMA, NMPA, EMA, FDA and similar authorities).
• Develop and manage an internal operational audit program to ensure effective internal and external audits and assessments and audits of subcontractors as appropriate. Ensure audits are documented, findings identified, and actions are created by responsible stakeholders and tracked through to resolution. Create Quality & compliance, external audit and internal audit reports and dashboards for senior executives.
• Guide account teams to develop appropriate quality related documentation per regulatory requirements (such as quality / technical agreements and vendor qualification protocols).
• Assist in continuous improvement activities throughout the business ensuring that problems are prevented and that customer requirements are met with any problems resolved effectively and economically.
• Work to prevent non-conformances, customer complaints, concession and rework alongside Operations to develop corrective and preventative actions within required timeframe.
• Liaise with the account management enablement teams to ensure compliance with JLL global client assurance programs. Support account teams with coaching and guidance on quality, risk, and compliance best practices and global standards.
• Continually improve the Quality Management System, updating procedures and train team members where required.
• Align implementation of ISO 9001 certification requirements with related global integrated management system requirements (ISO 14001 and ISO 45001) to support overall compliance management of account service delivery supporting Life Sciences clients.
• Interact with cross functional SMEs in each of the Life Sciences product delivery areas and participate in the development of the QRC framework at a global, regional, sub-regional and country level by industry to ensure all required playbooks, processes and standard operating procedures are in place, logged, named and numbered correctly on a central register and stored in a central repository.
• Provide QRC support to new Life Sciences business development initiatives, and enable quality and risk management programs at new accounts within region and global as needed.
• Understand and clearly communicate regulatory requirements to relevant accounts within the region, and apply these requirements to the compliance systems that JLL will develop for clients in these industries.
• Support account corrective actions definition and implementation, and support root cause analysis of identified non-compliance issues, events, and investigations.
• Work with external ISO accreditors to schedule external audits as and when required ensuring key stakeholders, SME’s are aware and available by country as required.
• Develop improvement and communication protocol within all systems and processes across the business Report on QRC activities on a regular basis to the Senior Management team, ensuring accurate and timely reporting of the relevant Key Performance Indicators.
• Partner with Environmental, Health and Safety, and Engineering to implement a behavioural approach to safety and a zero tolerance culture.
• Develop training materials for quality, risk, and compliance for employees at all levels.
• Work with the transition leader to ensure that the quality and risk framework minimum standards are included in all transitions and in place for go-live.
• Other quality, risk, and compliance tasks required to support regional operations.

The Candidate

The successful candidate will have a technical mindset, proven leadership, extensive regulatory and GxP experience, and strong management skills with the ability to engage, negotiate, and manage key stakeholders and suppliers. The candidate should be a strong and confident negotiator with the ability to engage internal and external stakeholders at all levels, excellent communication, interpersonal and influencing skills as well as excellent analytical and problem-solving abilities. The candidate will have extensive knowledge of the application of cGxP controls and requirements across global authorities, and will be a resource to the JLL account and client teams on the application of these controls to support compliant IFM service delivery. The candidate should be results orientated with ability to plan and deliver against project deadlines commercially and financially astute with experience of managing budgets. An appreciation of and an ability to positively resolve issues arising from different cultures.

Experience

• Educated to degree level in a relevant area of study. Bachelors or similar level degree (Desired: Engineering, statistics, or quality discipline or related). Advanced degree beneficial, or equivalent experience.
• At least 10 years’ experience in Quality or Operations required, at least 5 leading quality improvement programs.
• Demonstrable experience of leading a quality function with a proven track record in strategic quality leadership delivering effective quality strategies, policies, processes and systems and compliance to ISO accreditations.
• Experience implementing / managing ISO 9001-certified quality management systems.
• Experience managing QRC and operations within regulated and cGxP environments, including compliance to local health authority regulations and global standards (ICH Q9/Q10, ISO 9001 / 13485 / 14001 / 45001).
• Technical experience with facility and equipment qualification, and process and software validation.
• Certified Quality Auditor (internal or lead).
• Experience leading/managing a large, complex and geographically dispersed team.
• Experienced in root cause analysis and corrective and preventive action definition. Six Sigma Green / Black Belt experience preferred.
• Proven leader with extensive ability to build solid and collaborative relationships with team members that fosters a contagiously quality and compliance continual improvement culture.
• Ability to add value, reduce costs and make business improvements.
• Proven project management and cross-functional experience.
• Ability to communicate, effectively interface and influence multiple levels of executives and a broad range of internal and external customers.
• Chartered Membership of an industry related Professional Body, preferred.
• Other quality, risk, and compliance tasks required to support regional operations.

Skills

• Leadership Skills: A leader with exceptional communication skills coupled with excellent active listening skills. Ability to clearly articulate messages to a variety of audiences. Establish and maintain strong relationships on all levels of organization and with clients.
  Strong cultural alignment: unwavering ethical standards; drives excellence and innately collaborative.
  Strategic in nature, with a strong bias towards transformation and execution.
  Inspirational Leader, stimulates action with a balanced leadership style of control and influence.
  Operates with a sense of urgency.
  Decisive, willing to take risks.
• Influencing and Teamwork: Ability to influence others and move toward a common vision or goal. Able to work effectively at all levels in an organization. Must be a team player and able to work collaboratively with and through others.
• Project Management Skills: Knows how to effectively structure, staff and manage projects and teams to ensure there is clarity of expectation, timely execution, corrective action when needed and successful outcomes.
• Analytical Skills: Has a structured approach to problem solving with a natural inclination for systems thinking, planning strategy and tactics. Experience / qualification in Design Thinking will be of advantage.
• Character with high perseverance and resourcefulness required to keep driving and finding ways to get the required steps done. Flexible and adaptable; able to work in ambiguous situations. Resilient and tenacious with a propensity to persevere. Forward looking with a holistic approach.
• Client orientation: Keen focus on client needs, acutely focused on improving the client experience. Very high credibility in front of senior client audiences.

Behavioural Competencies

• Strategically adept.
• Possesses a customer mindset, internal and external.
• Cross-functional, collaborative, and culture-builder.
• Results oriented, constantly raising the bar.
• Proven leadership in both direct and project environments.