Top 136 Quality assurance manager Jobs in Malden Ma

Senior Manager, CMC QA
Ultragenyx Pharmaceutical —Bedford, MA
- $174,900 - $216,100 a year
- Full-time
- Hybrid work
- 7 years
- Bachelor's degree
- Team management
- Gym membership
4d
Quality Manager
Consigli Construction —Boston, MA
- $139,000 - $159,000 a year
- Full-time
- Construction site
- Engineering
- Mid-level
Quick Apply
Quality Manager
Connexion Systems and Engineering, Inc. —Lawrence, MA
- $85,000 - $115,000 a year
- Full-time
- 5 years
- Mentoring
- In-person
- Health insurance
- Dental insurance
Quick Apply
8h
Quality Manager (Heavy Civil Construction)
Skanska USA —Boston, MA
- $114,770 - $140,000 a year
- Full-time
- Background check
- Construction site
- 5 years
- Employee stock purchase plan
- 401(k) matching
Quality Control Manager (QCM), Federal Construction
Elite Recruiting & Consulting Services —Boston, MA
- Full-time
- Construction site
- 5 years
- Driver's License
- Health insurance
- Paid time off
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Quality Assurance Manager
Dana-Farber Cancer Institute —Boston, MA
- $130,000 - $142,000 a year
- Full-time
- Analysis skills
- Bachelor's degree
- Mentoring
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
Manager, GMP Quality Assurance, Clinical, QA
Agios Pharmaceuticals —Cambridge, MA
- $110,029 - $165,044 a year
- Remote
- 6 years
- Bachelor's degree
- Travel
- Health insurance
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
Senior Manager, Quality and Safety
Brigham and Women's Faulkner Hospital, Inc. —Boston, MA
- $99,465.60 - $144,643.20 a year
- Full-time
- Hybrid work
- Nursing
- Microsoft Excel
- Hospital
- Opportunities for advancement
Quick Apply
13d
Quality Systems Manager
Vor Bio —Boston, MA
- $170,000 - $180,000 a year
- 3 years
- Analysis skills
- Continuous improvement
- Health insurance
- 401(k)
Quality Systems Manager
Teleflex —Chelmsford, MA
- $127,000 - $190,500 a year
- Microsoft Excel
- Engineering
- 8 years
- Disability insurance
- Health insurance
Senior Manager, Quality Assurance
A.W. Chesterton Company —Groveland, MA
- $140,000 - $155,000 a year
- Full-time
- Background check
- 8 years
- Ability to lift 50 pounds
- Health savings account
- Paid holidays
11d
Sr. Manager, Manufacturing Quality
Symbotic LLC —Wilmington, MA
- $150,000 - $206,800 a year
- Full-time
- Hybrid work
- Up to 50% travel
- 5 years
- Engineering
- Health insurance
- Dental insurance
Quick Apply
Quality Manager (Onsite)
Collins Aerospace —Peabody, MA
- $107,500 - $204,500 a year
- Full-time
- 5 years
- Supervising experience
- In-person
- Paid holidays
- Loan repayment program
2d
International Quality Assurance Manager (Quality Management Systems)
AngioDynamics —Boston, MA
- $121,000 - $152,000 a year
- Full-time
- Office
- 3 years
- Ability to lift 50 pounds
Quick Apply
Manager, Quality Assurance
Rhythm Pharmaceuticals —Boston, MA
- $110,000 - $165,000 a year
- Full-time
- 5 years
- Office
- Travel
Manager, Quality Assurance Operations
Genetix Biotherapeutics —Boston, MA
- $118,000 - $166,000 a year
- Full-time
- Hybrid work
- 7 years
- Office
- Senior level
7d
Sr Manager, Quality and Change Management
Hologic —Marlborough, MA
- $134,700 - $224,500 a year
- Engineering
- 8 years
- Senior level
11d
Manager GMP Quality Operations
Vertex Pharmaceuticals —Boston, MA
- $118,400 - $177,600 a year
- Full-time
- Oracle
- Bachelor's degree
- Team management
- Loan repayment program
- Dental insurance

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quality assurance manager jobs near malden ma

Senior Manager, CMC QA

Ultragenyx Pharmaceutical -
Bedford, MA

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Job Details

Full-time
$174,900 - $216,100 a year
4 days ago

Benefits

Gym membership

Qualifications

GAMP
Clinical development
FDA 21 CFR Part 11
Project management experience in manufacturing
Production validation processes
Bachelor's degree
Team management
Release management
Quality assurance experience within pharmaceutical industry
Conflict management
Schedule creation
Regulatory submissions
Managing projects
Regulatory compliance analysis

Full Job Description

Why Join Us?

Be a hero for our rare disease patients

At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.

Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.

If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultrainnovative – Tackle rare and dynamic challenges

The Senior Manager, CMC QA will report to the Sr Director, CMC Quality Assurance. This role supports UGX QA Lot Disposition team performing tasks related to disposition and documentation activities for UGX and UGT product lots. This position is responsible for oversight and management of the Lot Release system, working proactively and cross-functionally to ensure lots are released according to schedule and Patient need.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

Work proactively with TechOps planning function, to ensure lot release dispositions are clearly and appropriately scheduled.

Work proactively to schedule and facilitate Production Planning meetings to ensure complete planning for production and subsequent lot release.

Ensure review CMO executed manufacturing batch records per QA SOPs, according to schedule and internal KPI requirements

Ensure Certificate of Analysis documents are evaluated and found to be accurate by QC group.

Understand QA systems such as raw material disposition, deviations, and change control to ensure batch records are compliant with these systems.

Ensure batch record history files are compiled and KPIs are updated and current.

Apply disposition to lots of material manufactured for Clinical, Early Access, and Commercial use. This includes, but not limited to, Starting Materials, DS, DP, FG.

Ensures archival of completed and reviewed manufacturing batch records

Drive change control accuracy, completeness, and transparency through the Change Review Forum

Perform the Change Control QA Role, where needed

Identify opportunities for improvement in Lot Release and Change Control, and use continuous improvement tools to drive implementation of improvements

Perform QMS data collection and trending for all APQR activities

Plan and coordinate cross-functional meetings with QP/QO/RP.

Other duties as assigned.

For DS/DP, ability to be authorized to assign lot disposition (releases lots)

Requirements:

Bachelor's degree in a science or related technical field with no less than 7 years relevant industry experience

Working knowledge of desktop computers

Demonstrated ability for detail-oriented work

This individual must exhibit strong compliance, organization, and communication skills.

In depth knowledge of pharmaceutical regulations including 21 CFR Part 11, GMPs, GCPs, GAMP 5, and Annex 11.

Extensive experience in managing multiple validation projects, developing plans, managing to project schedules and directing vendor/contract resources in creating CSV deliverables.

Diverse experience validating GxP-regulated applications for quality management, regulatory submissions, controlled document management solutions and clinical development

Must possess excellent communication, conflict resolutions, influence and problem-solving skills.

Deep understanding of the validation methodologies applied to on-prem applications and hosted environment.

Strong attention to detail, quality oriented

Must be self-motivated and comfortable in a fast-paced, demanding and dynamic work environment.

#LI-KJ1 #LI-Hybrid

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

Generous vacation time and public holidays observed by the company

Volunteer days

Long term incentive and Employee stock purchase plans or equivalent offerings

Employee wellbeing benefits

Fitness reimbursement

Tuition sponsoring

Professional development plans

Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected].

See our CCPA Employee and Applicant Privacy Notice.

See our Privacy Policy.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: [email protected].

Apply Now

Refine Your Search

quality assurance manager jobs in malden ma

Senior Manager, CMC QA

Quality Manager

Quality Manager

Quality Manager (Heavy Civil Construction)

Quality Control Manager (QCM), Federal Construction

Quality Assurance Manager

Sr. Manager, GMP Quality Assurance

Manager, GMP Quality Assurance, Clinical, QA

Quality Assurance Manager

Senior Manager, Quality and Safety

Quality Systems Manager

Quality Systems Manager

Senior Manager, Quality Assurance

Sr. Manager, Manufacturing Quality

Quality Manager (Onsite)

International Quality Assurance Manager (Quality Management Systems)

Manager, Quality Assurance

Manager, Quality Assurance Operations

Sr Manager, Quality and Change Management

Manager GMP Quality Operations

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