Top 172 Biotech Quality Manager Jobs

Strategic Training Partner, Senior Manager (Workforce Capability Architecture – Global Quality Management System)
Vertex Pharmaceuticals —Boston, MA
- $129,400 - $194,200 a year
- Full-time
- Hybrid work
- Master's degree
- Education
- Continuous improvement
- Loan repayment program
- Dental insurance
Senior Director, Quality Assurance (Drug Product)- Remote US
ARAVAS INC —Pennsylvania
- $220,000 - $245,000 a year
- Full-time
- Remote
- Bachelor of Science
- Data analysis skills
- 8 years
- Paid parental leave
- AD&D insurance
Quick Apply
AD/Director - Organizational Change Management Lead — Quality Transformation Portfolio (contract) 29471
Vertex Pharmaceuticals —Remote
- $90 - $100 an hour
- Full-time
- Analysis skills
- Continuous improvement
- Organizational skills
Senior Manager/AD, GCP & GVP, QA
Agios Pharmaceuticals —Cambridge, MA
- $131,035 - $230,312 a year
- Remote
- Project management
- Travel
- Senior level
- Health insurance
Quality Manager - 503b cGMP Environment
Wedgewood Pharmacy —Albany, OH
- From $110,000 a year
- Full-time
- 7 years
- Bachelor's degree
- Senior level
- Disability insurance
- Health insurance
Quick Apply
Quality Manager - 503b cGMP Environment
Wedgewood Pharmacy —Athens, OH
- From $110,000 a year
- Full-time
- 7 years
- Bachelor's degree
- Senior level
- Disability insurance
- Health insurance
Quick Apply
Executive Director, CMC QA
Ultragenyx Pharmaceutical —South San Francisco, CA
- $294,100 - $363,300 a year
- Microsoft Word
- Microsoft Excel
- Office
- Gym membership
10d
Head of Quality
Gallant —San Diego, CA
- From $150,000 a year
- Weekends as needed
- Background check
- Master's degree
- 8 years
- Health insurance
- Dental insurance
Quick Apply
Senior Manager, Global Quality Assurance
Medexus Pharma —Remote
- Remote
- Microsoft Excel
- Master's degree
- 8 years
External Quality Operation Manager (GMP)
Sobi —Raleigh, NC
- $120,000 - $140,000 a year
- Full-time
- Hybrid work
- 5 years
- English
- Senior level
- Health insurance
Quick Apply
Sr Manager, Quality Control
Kyverna Therapeutics —Remote
- $155,000 - $175,000 a year
- Full-time
- Remote
- Business development experience
- Bachelor's degree
- Travel
2d
Sr. Manager, GMP Quality Assurance
Deciphera Pharmaceuticals —Waltham, MA
- $138,000 - $190,000 a year
- Full-time
- Remote
- 8 years
- Bachelor's degree
- Travel
- Health insurance
- Dental insurance
Quick Apply
Director, Clinical and Pharmacovigilance Quality
LB Pharmaceuticals —New York, NY
- $200,000 - $215,000 a year
- Full-time
- Remote
- 5 years
- Bachelor's degree
- Travel
Quick Apply
12d
MANAGER / SENIOR MANAGER QUALITY MANAGEMENT SYSTEM & VEEVA QUALITY SYSTEMS ADMINISTRATION
Karyopharm Therapeutics Inc. —Newton, MA
- $150,000 - $180,000 a year
- Full-time
- Microsoft Word
- Bachelor of Science
- Adults
- Health insurance
- Dental insurance
Quality Manager
Thermo Fisher Scientific —Fair Lawn, NJ
- $112,500 - $155,000 a year
- Full-time
- 5 years
- Bachelor's degree
- Mentoring
- Commuter assistance
- Paid parental leave
8d
Senior Manager, Operational Area Quality (Combination Products)
Vertex Pharmaceuticals —Boston, MA
- $133,800 - $200,600 a year
- Full-time
- Hybrid work
- Engineering
- Senior level
- Leadership
- Loan repayment program
- Dental insurance
10d
Senior Director, Quality Control
CG Oncology Inc —Remote
- $230,000 - $270,000 a year
- Full-time
- Remote
- 5 years
- Laboratory experience
- Travel
- Health savings account
- Disability insurance
Quick Apply
Quality Assurance Manager
Ardelyx —Waltham, MA
- $139,000 - $169,000 a year
- Full-time
- Hybrid work
- Office
- Bachelor's degree
- SharePoint
- Paid parental leave
- Paid holidays
GMP Operational Quality Manager
Vertex Pharmaceuticals —Boston, MA
- $118,400 - $177,600 a year
- Full-time
- Hybrid work
- 5 years
- Analysis skills
- Bachelor's degree
- Loan repayment program
- Dental insurance
Head, QA Ops and Compliance (Associate Director Level)
Novartis —Durham, NC
- $138,600 - $257,400 a year
- Full-time
- Bachelor of Science
- English
- Bachelor's degree
- Health insurance
- 401(k) matching

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Strategic Training Partner, Senior Manager (Workforce Capability Architecture – Global Quality Management System)

Vertex Pharmaceuticals -
Boston, MA

Apply Now

Job Details

Full-time
$129,400 - $194,200 a year

Benefits

Loan repayment program
Dental insurance
Tuition reimbursement
Paid time off
Vision insurance
401(k) matching

Qualifications

Stakeholder engagement
Program design
GxP
Process design
Needs assessment for curriculum design
Policy & process development
Continuous improvement
Content development
HR systems
Educational program evaluation
ICH Q10
Training outcomes evaluation for professional development
Developing new training programs
E-learning platforms
Assessment instructional content development
Regulatory and compliance training (healthcare teaching and curriculum development)
Enterprise Learning Management
Quality systems
Business requirements
Learning and development strategy
Stakeholder management

Full Job Description

Job Description

Role Summary:

The Strategic Training Partner serves as a Workforce Capability Architect for the global QMS , responsible for designing how processes are translated into role-based capabilities, qualifications, and training programs across all quality value streams.

This role partners with Quality System Owners, Process Architects, and Digital Quality Systems to ensure that:

training reflects true process execution
capabilities are role-based and risk-based
training is fully integrated with documentation, systems, and change management

This role requires expertise in capability design and architecture.

What You Will Own:

Process-to-Capability Architecture

Translate process design into role-based capability models by:

Converting value streams and process maps into:
- role definitions
- required competencies
- capability frameworks
Definitions of what people must be able to do , not just what they must read
Ensure alignment between:
- process steps
- system interactions
- required skills

Global Training & Qualification Framework

Define and implement risk-based training that qualifies colleagues to perform GxP processes within a regulated environment.

Role-based training models
Curriculum design standards
Qualification and requalification strategies
Risk-based training approaches (not one-size-fits-all)

Ensure global consistency across:

sites
functions
modalities

Training Integration Across Value Streams

Ensure training is embedded within end-to-end value streams by:

Aligning training with:
- Quality Event & CAPA
- Change Control
- Supplier Quality
- Documentation updates
Ensure training is triggered by:
- process changes
- SOP updates
- system changes
- defined business requirements

Holistically assess training content to prevent:

training that is disconnected from executable tasks or regulatory requirements
redundant or low-value training

Training Effectiveness & Capability Assurance

Move beyond training completion to true capability assurance by:

Defining how training effectiveness is measured:
- performance outcomes
- error reduction
- CAPA actions
Identifying capability gaps through:
- deviation trends
- audit findings
- inspection observations
Establishing feedback loops between:
- performance data
- training improvements
- KPI outputs

Digital Alignment (LMS / QMS Integration)

Ensure training is digitally enabled and integrated by:

Aligning training models with LMS and QMS systems
Ensuring correct training triggers from:
- document updates
- change control
- CAPA actions
- business requirements
Supporting automation of:
- training assignments
- on-the-job training recertifications
- qualification tracking

Change Impact & Synchronization

Define how training evolves with system changes & ensure training updates are synchronized with:

documentation
process changes
system updates

Define impact assessment models for:

new processes
updated procedures

Prevent misalignment between:

what is written
what is trained
what is executed

Inspection Readiness & Regulatory Alignment

Ensure training and qualification meet expectations aligned to

ICH Q10 Pharmaceutical Quality System by ensuring GxP training is:

role-based
traceable
inspection-ready
Supports inspection preparation and responses
Demonstrates that personnel are qualified, not just trained

Continuous Improvement of Workforce Capability

Drive evolution of how the organization builds capability by introducing and refining modern learning approaches:

role-based learning
just-in-time training
risk-based curricula
Reduction of unnecessary training burden
Assessments for workforce effectiveness and personnel performance

Role Requirements:

8–12+ years in GxP Quality, Training, or Learning & Development
Bachelor’s degree in Instructional Design, Education, Life Sciences, or related field; Master’s degree preferred.
Experience designing global training and qualification frameworks
Strong understanding of QMS processes and regulatory expectations
Experience with LMS platforms (e.g., Cornerstone, SuccessFactors)
Experience with process mapping / value streams preferred
Ability to translate process requirements into capability models
Strong stakeholder influence in global, matrixed environments

Pay Range:

$129,400 - $194,200

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid : work remotely up to two days per week; or select
2. On-Site : work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]

Apply Now

Refine Your Search

Biotech Quality Manager jobs

Strategic Training Partner, Senior Manager (Workforce Capability Architecture – Global Quality Management System)

Senior Director, Quality Assurance (Drug Product)- Remote US

AD/Director - Organizational Change Management Lead — Quality Transformation Portfolio (contract) 29471

Senior Manager/AD, GCP & GVP, QA

Quality Manager - 503b cGMP Environment

Quality Manager - 503b cGMP Environment

Executive Director, CMC QA

Head of Quality

Senior Manager, Global Quality Assurance

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Sr Manager, Quality Control

Sr. Manager, GMP Quality Assurance

Director, Clinical and Pharmacovigilance Quality

MANAGER / SENIOR MANAGER QUALITY MANAGEMENT SYSTEM & VEEVA QUALITY SYSTEMS ADMINISTRATION

Quality Manager

Senior Manager, Operational Area Quality (Combination Products)

Senior Director, Quality Control

Quality Assurance Manager

GMP Operational Quality Manager

Head, QA Ops and Compliance (Associate Director Level)

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