APAC R&D Quality & Compliance Lead - 2407018033W

Description

What You Will Do

The Associate Director, R&D Q&C provides leadership, direction and Quality oversight primarily Shanghai Technology and Research Center (China) (65% to 70%) and supports other research centres in Asia Pacific eg Mumbai R&D Laboratories. This role deploys and maintains quality systems and controls that are appropriate, effective, efficient and continuously improving in order to ensure full compliance with sound scientific practice, Current Good Manufacturing Practices(cGMP), Good Laboratory Practices (GLP) and Good Documentation Practices (GDP), and within corporate policies and procedures. The incumbent partners with cross functional technical teams such as Material, Packaging, Analytical for the delivery of R&D project strategy, innovation and technical projects with a deep understanding of our business, regulatory requirements and our consumers. The incumbent will foster a culture of innovation and continuous improvement , by enabling new ways of working, implementing process improvements where needed, and collaborating with peers and cross-functional team teams to scale best practices

Key Responsibilities

• Lead China R&D Q&C team through the delivery of projects to support our business objectives and priorities with deep understanding of regulatory requirements preferably NMPA (China HA) for drug/OTC, cosmetics and medical devices

• Lead implementation of quality systems and controls that are appropriate, effective and efficient to ensure product development process comply to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).

• Drive and influence a culture of agility, discipline, and consumer centricity throughout the innovation process.

• Improve R&D operation productivity in NPI/NPDs workflows to deliver high quality services, secure speed to market goals, create value focusing on quality handoffs. By implementing robust processes in STAR, interface with the research centres, drive improvement in scale up, product transfers, analytical methods, clinical studies with consistent procedures and processes that will improve productivity and efficiency, and support .

• Support AP leadership to realise it’s quality vision for STaR as a Asia Pacific Centre of Excellence, the leader shall inspire a strong quality team who drives operational excellence by effectively using continuous improvement skills and risk management tools to improve product quality, reduce costs of poor quality and align with strategic objectivies.

• Evaluates procedures, systems and processes and their impact on business practices and compliance to regulations, as well as implement programs crafted to increase employee awareness and knowledge of compliance requirements/policies

• Coordinate and communicate with cross-functional technical teams to ensure alignment and collaboration throughout the project lifecycle.

• Consistently identifies and advocates improvements that are fit for purpose

• Participates and/or leads activities relating to Health Authority inspections/corporate audits, collaborating closely with R&D and other Quality & Compliance organizations as appropriate.

• Participates in and supports impact assessment and risk analysis as new regulations become effective

• Reviews and releases GMP documentation including, but not limited to standard operating procedures, specifications, product risk management reports, change controls, deviations/investigations, CAPAs, and Quality Agreements.

• Review of project briefs from a technical perspective with all stakeholders and support the development of the project plan, milestones, and resource requirements

• Ensure projects are continuously evaluated against success metrics and identify work plans to address areas of concern

• Engage and promote a community of practice among the teams with a consumer-centric, growth mindset to guide the appropriate projects results

Qualifications

What We Are Looking For

Required Qualifications

• At minimum, Bachelor's degree on Pharm, Chemistry or Science/Engineering. Master's degree is desirable

• Extensive experience in in the field of R&D Quality in a global/international Healthcare industry preferably Pharma industry

• Minimum 10 years of R&D technical quality experience in managing or leading complex technical projects

Required Knowledge, Skills and Abilities:

• Expert knowledge of applicable regulatory requirements governing various product classification types (cosmetic, OTC/OTC Monograph and Medical Devices)

• Role model with high commitment to quality

• Experience of the overall product development process

• Rich experience in leading Health Authority inspections is highly desirable.

• Ability to lead in ambiguous and uncertain situations

• Ability to provide guidance, collaborate, negotiate, and effectively coach and direct departmental staff and others to ensure an ongoing state of compliance.

• Ability to engage and align with diverse and dispersed organizations and functions.

• With big picture orientation and end-to-end mindset

• Ability to independently work and make decisions

• Problem solver and proactive strategic thinker

• Strong leader and cross-functional collaborator

• Flexible and persistent

• Ability to influence without authority, overcome challenges, and effectively negotiate with colleagues across levels and functions

• Excellent communicator with outstanding social skills and tact and good command of Chinese and English language

• Ability to allocate and balance resources across competing priorities; identify opportunities and solutions, and mentor others to do the same.

What’s In It For You

• Competitive Benefit Package

• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!

• Learning & Development Opportunities

• Employee Resource Groups

Primary Location Asia Pacific-China-Shanghai-Shanghai

Job Function Quality Assurance

Req ID: 2407018033W