Quality & Risk Director Job at Encompass Health (Mechanicsburg)

Japan Quality Director

Lead quality assurance and compliance for a global biopharmaceutical leader in J...

Location

Japan , Tokyo

Salary:

18000000.00 - 22000000.00 JPY / Year

Randstad

Expiration Date

March 12, 2026

Requirements

Bachelor's degree in pharmacy, life sciences, or a related field
Minimum 10 years of experience in the pharmaceutical industry, with at least 7 years in Quality Management Systems
Expert knowledge of GMP, GDP, and Japanese pharmaceutical regulations
Proven experience leading and managing a team of quality assurance professionals
Strong understanding of quality risk management principles and techniques
Excellent communication and collaboration skills, including fluency in Japanese and English
Proven ability to interact effectively with health authorities and external partners
Strong leadership skills with the ability to build consensus and drive results
Experience with SAP systems is preferred
Experience in product recall and field action management

Job Responsibility

Implement and maintain the Local Quality Management System (QMS)
Oversee quality control for pharmaceutical products, ensuring compliance with GMP/GDP standards
Manage deviations, CAPAs, complaints, and change control processes
Lead supplier management, including qualification and selection of new vendors
Represent the company with health authorities and other external stakeholders
Collaborate with global quality teams, ensuring consistent application of quality standards
Manage and develop a team of quality assurance professionals
Lead internal audits and inspections, ensuring regulatory compliance
Manage product recalls and field actions, collaborating with various teams and stakeholders

What we offer

Health insurance
Employee pension insurance
Unemployment insurance
Weekends and public holidays off

Fulltime

Audit Director, Quality & Compliance

The Audit Director is responsible for leading the strategy, execution, and conti...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Quality, Regulatory, or related discipline
10+ years of GxP audit experience in biotechnology, pharmaceutical, or cell therapy environment
Demonstrated experience leading internal and external GxP audits
Strong understanding of FDA, EMA, MHRA, and ICH regulations (including ICH E6 R3, Annex 1, 21 CFR Parts 210/211/312/820, GCP/GMP/GLP)
Experience supervising or mentoring employees
Strong analytical, organizational, and communication skills
Ability to manage competing priorities in a fast-paced, rapidly growing company
Experience in advanced therapies, ATMPs, or cell/gene therapy manufacturing preferred
Experience preparing for and supporting regulatory inspections preferred
Certifications such as ASQ, RQAP-GCP/GMP, RAC, CQA, or equivalent preferred

Job Responsibility

Develop and maintain the annual risk-based Internal Audit Program across GCP, GMP, GLP, IT/CSV, and Quality Management System (QMS) domains
Plan, schedule, and execute internal audits, vendor audits, and for-cause audits
Ensure alignment with global regulatory requirements and industry best practices for advanced therapies and cell therapy manufacturing
Evaluate organizational risk and adjust audit scope and approach accordingly
Directly supervise the current audit team member including goal setting, workload planning, performance management, and professional development
Provide coaching, technical training, and oversight to ensure audit readiness and consistent application of audit standards
Support team succession planning and capability building as the audit function grows
Lead or oversee audits of internal functional areas (e.g., Clinical Operations, CMC, MSAT, Manufacturing, Quality Control, Regulatory Affairs, IT)
Oversee vendor and third-party audits to qualify and maintain GxP suppliers
Ensure timely issuance of audit reports, management responses, and CAPA plans

What we offer

health and retirement, PTO, and stock option plans

Senior Director Quality Assurance

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , West Greenwich

Salary:

218358.00 - 252850.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience
Master’s degree and 8 years of Quality/Manufacturing/Engineering experience
Bachelor’s degree and 10 years of Quality/Manufacturing/Engineering experience
At least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead Plant QA team providing Quality Oversight of 24/7 continuous manufacturing operation and high impact strategic decision making in two (2) multi-product Drug Substance facilities
Scope includes on-the-floor support for AR5 Fed batch and AR30 MoF, I-530, Buffer Preparation Area, Media Preparation, Component Preparation Area, In Process Testing Lab, record review, quality oversight of deviation investigations and changes, document approval, and disposition
Ensure drug substance is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and other applicable regulations and specifications
Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards
Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies
Provide quality input and partner with cross-site and cross-functional area leads to advance Amgen’s manufacturing strategy
Develop strategies in support of regulatory inspections and site audits
Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties
Develop area budget, manage expenditure and identify productivity improvement opportunities
Represent ARI Quality in cross-function and cross-site forums

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans

Fulltime

Director, Quality

Leads and oversees a comprehensive, efficient, and integrated hospital-wide Cont...

Location

United States , Waukesha

Salary:

Not provided

Copper Springs East

Expiration Date

Until further notice

Requirements

Registered Nurse with current state licensure highly preferred
clinical license required
BSN or BS/BA required
Minimum two (2) years in an acute hospital or rehabilitation setting required
prior supervisory experience preferred
Basic Life Support (BLS/CPR) required
certification preferred by APIC (American Practitioners of Infection Control) and NAHCQ (National Association of Health Care Quality)
Data analysis and reporting
CQPI methodologies (e.g., RCA, FMEA, PDSA)
risk management and patient safety facilitation

Job Responsibility

Provide leadership and oversight of the organization-wide CQPI program
Measure and assess performance by collecting, analyzing, and trending data to identify opportunities for improvement
Focus on improving processes and systems to drive clinical quality, safety, and operational performance
Direct, facilitate, and report on all aspects of risk management and patient safety
Investigate factors contributing to adverse outcomes and drive process/system changes
Direct the hospital-wide CQPI operations, including record reviews for quality indicators and reporting findings to leadership, Medical Executive Committee, Board of Managers, and other committees
Annually review hospital-wide plans for Infection Control (IC) and CQPI
establish goals and objectives for the coming year
Serve as liaison to local health officials
coordinate inspections and accreditation reviews with state and other regulatory agencies

What we offer

Health (Medical, Dental, Vision) and 401K Benefits for full-time employees
Competitive Paid Time Off
Employee Assistance Program - mental, physical, and financial wellness assistance
Tuition Reimbursement/Assistance for qualified applicants

Fulltime

Financial Crimes Risk Director

The Financial Crimes Risk Director role is a first line function responsible for...

Location

Singapore , Singapore

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Bachelor’s/University degree required
master’s degree desirable
15+ years’ experience in financial crime compliance or risk management
Financial Crime certification preferred (ACAMS, ACSS etc.)
Strong understanding of international Sanctions
Strong professional experience in Financial Services, in Financial Crime Compliance and/or Financial Crime Risk & Controls
Knowledge and understanding of Payments, Correspondent Banking, Trade, Working Capital, and Liquidity Management products
Excellent interpersonal skills
Able to work independently and deliver according to strict timelines and quality standards
Demonstrated ability and confidence to challenge business management, escalate issues and press for change

Job Responsibility

Understand business-owned products, services, as well as corresponding financial crimes-related controls, and processes
Provide financial crimes compliance/risk management subject matter expertise to the Services businesses in Asia to ensure the design and implementation of a coherent and effective control environment
Assess complex issues, structure potential solutions, and drive effective resolution with other senior stakeholders
Assess existing control framework, identify potential compliance gaps
Drive execution ensuring compliance with applicable laws, rules, and regulations, as well as effectiveness of the control environment
Ensure adequate mapping of risk and processes and clear control ownership
Create & maintain a robust partnership with the business heads, operations, technology and the second line of defense
Ensure clear and timely escalation of control issues, while assisting their adequate management and internal reporting
Drive a consistent and holistic approach to Financial Crimes risk management across Services
Ensure early engagement on new business initiatives to ensure timely support of commercial priorities and full adherence to global and regional risk management policies and procedures

Fulltime

Director of Quality

As the Director of Quality, you will be responsible for leading operational qual...

Location

United States , Union City

Salary:

216481.00 - 237601.00 USD / Year

BillionToOne

Expiration Date

Until further notice

Requirements

8+ years quality leadership experience in a CLIA-certified laboratory environment with demonstrated ability to lead and manage people and teams
Deep understanding of CLIA, CAP, state laboratory regulations (including NYS Clinical Lab requirements)
Proven track record of successfully reducing quality issues through systematic improvement initiatives
Hands-on experience with supplier quality management, including qualification, auditing, and corrective action management
Experience implementing or optimizing quality processes in a regulated laboratory setting
Strong analytical skills with ability to analyze quality data, identify trends, and develop data-driven solutions
Demonstrated ability to work cross-functionally and influence without direct authority
Ability to work independently and cross-functionally to provide effective updates at executive level
Detail-oriented with well-developed organizational and problem-solving skills
Proven ability to communicate effectively both in writing and verbally with staff at all levels

Job Responsibility

Lead and execute operational quality programs including incident management, material management, supplier management, trending/monitoring, and compliance
Drive continuous improvement initiatives by conducting root cause analyses, implementing corrective actions, and optimizing processes to reduce nonconformances and enhance laboratory efficiency
Partner directly with Lab Operations, Supply Chain, R&D, and other stakeholders to solve problems and embed quality into daily workflows
Serve as subject matter expert for operational quality matters
personally lead critical investigations and improvement projects as needed
Driving systematic reduction of quality issues through root cause analysis, trend identification, and implementation of sustainable corrective actions
Establishing and tracking operational quality metrics (NCR, CAPA, Change Control, Preventive Maintenance, etc.) to drive data-driven decision making
Developing risk-based receiving inspection protocols that balance quality assurance with operational efficiency
Establishing acceptance criteria and sampling plans for incoming materials, reagents, and consumables
Ensuring laboratory quality systems operate effectively to support daily operations

What we offer

Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
Open, transparent culture that includes weekly Town Hall meetings
The ability to indirectly or directly change the lives of hundreds of thousands patients
Multiple medical benefit options
employee premiums paid 100% of select plans, dependents covered up to 80%
Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
Supplemental fertility benefits coverage
Retirement savings program including a 4% Company match
Increase paid time off with increased tenure
Latest and greatest hardware (laptop, lab equipment, facilities)

Fulltime

Deputy Director - Quality (Medical Coding)

We are seeking an experienced Medical Coding leader to join our team in Chennai ...

Location

India , Chennai

Salary:

Not provided

Access Healthcare LLC

Expiration Date

Until further notice

Requirements

Deep understanding of medical coding standards and audit processes
Experience with automation and AI solutions in coding audits
Proficiency in developing and managing quality metrics dashboards
Strategic leadership and ability to influence cross-functional teams
Strong problem-solving and decision-making capabilities
Excellent communication and stakeholder management skills
Minimum 13 years of experience in Healthcare Revenue Cycle Management (RCM) and Quality Assurance
At least 5 to 6 years of core multispecialty coding expertise
Certified Six Sigma Black Belt/Master Black Belt from recognized institutions (e.g., ISI, ASQ, Benchmark, KPMG) with proven project experience
Expertise in coding audit frameworks, accuracy improvement strategies, and regulatory compliance

Job Responsibility

Oversee comprehensive quality audits for coding across in-house teams and multiple vendors
Enforce coding best practices to mitigate risks such as missed diagnoses, over-coding, or under-coding
Drive external and internal audit programs aimed at improving compliance and accuracy
Design and elevate quality control frameworks to ensure coding accuracy and operational efficiency
Lead initiatives to reduce error rates, enhance coding precision, and boost productivity
Implement cutting-edge, AI-enabled audit solutions such as automated coding reviews and real-time QA tools
Monitor and report on Accuracy KPIs, including Missed Error Rate, Extra Error Rate, and Inter-Rater Reliability
Utilize robust data analytics to assess trends in coding accuracy and identify compliance risks
Develop executive dashboards and reports to provide insights into quality performance metrics
Partner with Operations and Training teams to address and resolve coding discrepancies while implementing corrective action plans

Director-Quality Engineering -Wealth Tech

The IT Senior Group Manager manages multiple teams through other managers. In-de...

Location

India , Chennai; Pune

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

15+ years of experience in multiple technology disciplines with extensive experience in business, functional and people management
Budget management, Risk & Control management, influencing skills
Experience in automated testing
Managerial experience
Bachelor’s/University degree, Master’s degree preferred

Job Responsibility

Ensures managed areas are defining and implementing systems that are aligned with business strategy and goals
Resolves a variety of broad based and complex issues
Applies a broad and comprehensive understanding in multiple functional areas as well as underlying business principles
Demonstrates an in depth understanding of how own sub function integrates within the overall technology function to achieve objectives
Provides evaluative judgment based on analysis of factual information in complicated, unique and dynamic situations
Impacts the technology sub function by strategic influence and by exercising control over resources, budget management and planning
Influences and negotiates with senior leaders (across functions)
Appropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Citigroup, its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgment regarding personal behavior, conduct and business practices, and escalating, managing and reporting control issues with transparency, as well as effectively supervise the activity of others and create accountability with those who fail to maintain these standards

Fulltime

Quality & Risk Director

Encompass Health

Location:
United States , Mechanicsburg

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 04, 2026

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Quality & Risk Director

Encompass Health

Location:United States , Mechanicsburg

Category:Quality Control

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:February 04, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Quality & Risk Director

Japan Quality Director

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Location:
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Contract Type:
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Job Posted:
February 04, 2026