Director - Global Quality Compliance

Position Summary

The Director, Global Quality Compliance is

a senior enterprise leadership role accountable for shaping and advancing GMP compliance,

quality risk management, and continuous improvement across WuXi Biologics’ global network in China, the United States, Europe, and Asia.

The role establishes globally consistent,

risk-based compliance expectations while enabling effective execution at site

and functional levels. It provides strategic oversight across biologics drug

substance and drug product operations, sterile drug products, quality control

laboratories, combination products, and emerging modalities, supporting

products from clinical development through commercialization in multiple

markets.

The successful candidate will be a credible GMP

authority and influential enterprise leader who can translate evolving

regulatory expectations into practical governance, anticipate systemic compliance

risk, guide senior stakeholders, and lead complex cross-functional remediation

and transformation programs.

Key Accountabilities

1. Global GMP Compliance Strategy &

Governance

·

Shape

and execute the global GMP compliance and quality risk management strategy in

alignment with business priorities, product lifecycle needs, and regulatory

commitments.

· Establish and sustain

harmonized global policies, standards, governance structure and practice, and

performance mechanisms based on applicable regulations, guidance, and industry

best practices.

· Define enterprise compliance

risk criteria, maintain a global risk register, and ensure timely escalation,

mitigation, and leadership visibility of significant risks.

· Assess the effectiveness and

health of pharmaceutical quality systems at global and site levels, including

deviation management, CAPA, change control, data integrity, and management

review.

·

Drive

consistent interpretation of global requirements while enabling fit-for-purpose

site execution and clear accountability.

2. Regulatory Intelligence & Compliance

·

Maintain oversight of evolving requirements and

expectations from FDA, EMA, NMPA, PMDA, PIC/S, ICH, and other health

authorities and standards-setting bodies.

· Lead the

global process for regulatory intelligence, impact assessment, gap analysis,

prioritization, implementation, and effectiveness verification.

· Translate

new regulatory, compendial, and technical expectations into practical global

standards and implementation plans.

· Provide

authoritative compliance guidance for complex or high-risk issues and support

defensible, science- and risk-based decisions.

3. Inspection Readiness &

Regulatory Response

·

Set the global framework for sustained

inspection readiness across manufacturing sites, laboratories, and relevant

corporate functions.

· Provide

leadership and subject-matter support for significant regulatory inspections,

including preparation, inspection conduct, response strategy, and

post-inspection remediation.

· Ensure

observations and commitments are assessed for systemic impact, addressed

through robust CAPA, and verified for effectiveness across the network.

· Identify

inspection trends and recurring vulnerabilities, and sponsor enterprise-level corrective

and preventive improvement.

4. Global Audit &

Compliance Oversight

·

Design and lead a risk-based global audit and

oversight strategy covering internal sites, suppliers, contract laboratories,

computerized systems, and other GxP service providers.

· Provide

governance for regulatory inspections, critical client and partner audits and

support coordinated preparation, response, and follow-up.

· Set

expectations for auditor qualification, audit planning, report quality, finding

classification, CAPA robustness, and effectiveness verification.

· Analyze

audit data and trends to identify systemic risk and prioritize network-wide

remediation and continuous improvement.

5. Digital, Computerized

Systems & AI Compliance

·

Advise on GxP compliance of data integrity,

validation, and lifecycle controls for computerized systems, digital

transformation, automation, and AI-enabled solutions.

· Help

establish risk-based governance for the selection, development, validation,

deployment, monitoring, change, and retirement of GxP digital and AI solutions.

· Partner with

Quality, IT, Digital, Data, Legal, and business functions to ensure innovation

is implemented with appropriate controls, accountability, and regulatory

defensibility.

6. New Businesses, Modalities

& Product Lifecycle

·

Provide compliance leadership for new or

expanding businesses, facilities, technologies, and modalities, ensuring

fit-for-purpose quality systems are established early and scaled appropriately.

· Advise on

quality and regulatory considerations for combination products, including

drug–device interfaces, and for antibody conjugates and other innovative therapeutic

protein platforms.

· Support due

diligence, technology transfer, launch readiness, and lifecycle changes where

significant GMP compliance risk is present.

7. Enterprise Leadership

& Quality Culture

·

Build, lead, and develop a high-performing

global compliance team and broader network of quality professionals, as

applicable.

· Influence

senior leaders across functions and regions and promote a strong quality

culture, transparent escalation, and risk-based decision-making.

· Chair or

contribute to senior governance forums and communicate compliance health,

emerging risk, and remediation status clearly and concisely.

· Serve as a

trusted advisor to executive and site leadership on strategic initiatives,

significant quality events, and complex regulatory matters.

·

Define meaningful metrics and management

insights that drive accountability, early intervention, and sustainable

improvement.

Required Qualifications

o

Bachelor’s degree in life science, health

sciences, regulatory science, biomedicine or a related discipline; an advanced

degree is preferred.

o Typically

12+ years of progressive quality compliance, or regulatory experience in a

regulatory agency, biologics, biopharmaceuticals, or CDMO/CMO environments,

including substantial leadership responsibility.

o Demonstrated

success leading global or multi-site GMP compliance programs and influencing

outcomes at senior leadership level.

o Deep working

knowledge of pharmaceutical quality systems and GMP compliance across biologics

drug substance and drug product operations, sterile manufacturing, and quality

control laboratories.

o Strong

command of major global GMP frameworks and regulatory expectations, with the

ability to interpret requirements and apply sound scientific and risk-based

judgment.

o Proven leadership

in regulatory inspections, complex audits, significant compliance

investigations, and enterprise-scale remediation or transformation programs.

o Ability to

identify systemic risk, set priorities under ambiguity, and balance compliance,

patient protection, operational realities, and business continuity.

o Exceptional

executive communication, stakeholder influence, negotiation, and

decision-making skills in a global matrix organization.

o Fluency in

English and Chinese, with the ability to communicate complex quality and

regulatory matters clearly across cultures and functions.

Preferred Experience

·

Experience gained in a leading multinational

biopharmaceutical company, global CDMO, or health authority.

· Leadership

of major pre-approval, routine GMP, or for-cause inspections and successful

post-inspection remediation.

· Experience

supporting innovative biologics across clinical, pre-licensure, launch, and

post-licensure phases in multiple markets.

· Expertise in

data integrity, computerized-system compliance, and risk governance for digital

and AI-enabled GxP applications.

· Experience

with combination products, antibody conjugates, advanced manufacturing

technologies, or other emerging modalities.

· Demonstrated

ability to develop global talent, lead through influence, and embed sustainable

quality culture change.

Leadership Profile

·

Enterprise mindset: Connects regulatory

expectations, patient protection, operational performance, and long-term

business strategy.

· Judgment and

courage:

Makes timely, principled decisions and escalates material risk with clarity and

independence.

· Global

influence:

Builds trust across cultures, functions, sites, and leadership levels

· Execution

excellence: Converts strategy into scalable and sustainable standards,

ownership, milestones, and outcomes.

· Continuous

improvement: Uses data, trends, lessons learned, and external insight

to strengthen compliance maturity.