Top 70 Data integrity program manager quality control Jobs in Worcester, Ma

Data Integrity Program Manager - Quality Control
Rentschler Biopharma SE —Milford, MA
- $120,000 - $150,000 a year
- 8 years
- Organizational skills
- Senior level
- Health insurance
- 401(k)
Resident Chef (Sur La Table)
CSC Generation —Natick, MA
- Weekends as needed
- Mid-level
- Ability to lift 50 pounds
- 21 years or older
- Flexible schedule
Quick Apply
Digital Transformation Program Manager
Avecia —Milford, MA
- $152,600 - $186,700 a year
- Full-time
- 5 years
- Engineering
- Senior level
Scientist, Quality Control (QC) Systems
Bristol-Myers Squibb —Devens, MA
- $107,100 - $129,780 a year
- Email
- Hybrid work
- 6 years
- Mid-level
- Continuous improvement
- Paid holidays
- Disability insurance
16h
Quality Manager
Nelson Miller Group —Fitchburg, MA
- $95,000 - $110,000 a year
- Full-time
- Background check
- Computer literacy
- Engineering
- AD&D insurance
- Paid holidays
Sr. Associate, Serialization and Packaging
Replimune —Framingham, MA
- $103,500 - $133,500 a year
- Full-time
- Oracle
- Mid-level
- High school diploma or GED
Quick Apply
Manager, GMP Cleaning Program and Projects Lead
Bristol-Myers Squibb —Devens, MA
- $114,100 - $138,267 a year
- Email
- Hybrid work
- Engineering
- Travel
- Fair chance
- Paid holidays
- Disability insurance
Sr Manager, Regulatory Operations
Hologic —Marlborough, MA
- $145,000 - $241,800 a year
- Word processing
- Computer literacy
- Bachelor of Science
15h
Senior Manager, Quality Assurance Material Operations, Cell Therapy
Bristol-Myers Squibb —Devens, MA
- $130,020 - $157,559 a year
- Email
- Hybrid work
- 8 years
- Travel
- Conflict management
- Paid holidays
- Disability insurance
10d
Quality Engineer II, Product
Olympus —Westborough, MA
- $82,862 - $111,864 a year
- Full-time
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Engineering
- Paid parental leave
- Paid holidays
Manager, Commercial Packaging and Serialization
Replimune —Framingham, MA
- $121,000 - $157,500 a year
- Full-time
- Oracle
- 5 years
- Bachelor's degree
Quick Apply
Sr. Internal Audit Manager
IPG Photonics —Marlborough, MA
- $131,000 - $162,000 a year
- Full-time
- Management
- CPA
- ERP systems
- Health savings account
- AD&D insurance
Quick Apply
Director, Operations (Manufacturing)
Lenze Americas Corporation —Uxbridge, MA
- $150,000 - $212,750 a year
- 5 years
- Engineering
- Office
7d
Specialist, Quality Assurance Shop Floor, Cell Therapy
Bristol-Myers Squibb —Devens, MA
- $40.16 - $48.67 an hour
- 12 hour shift
- Hybrid work
- Computer literacy
- Mid-level
- High school diploma or GED
- Paid holidays
- Disability insurance
Sr Manager QA Technical Operations
Bristol-Myers Squibb —Devens, MA
- $130,020 - $157,559 a year
- Email
- Hybrid work
- 5 years
- Bachelor of Science
- Engineering
- Paid holidays
- Disability insurance
2d
Senior Facilities Engineer
AbbVie —Worcester, MA
- $84,500 - $162,000 a year
- Full-time
- Hybrid work
- Writing skills
- Engineering
- Warehouse
- Paid holidays
- Health insurance
Data Manager
Chickasaw Nation Industries —Natick, MA
- Full-time
- 5 years
- Office
- SQL
- AD&D insurance
- Disability insurance
10d
Senior Manager, PMO Portfolio Management
Olympus —Westborough, MA
- $137,657 - $192,722 a year
- Full-time
- Hybrid work
- Microsoft Word
- Bachelor of Science
- Engineering
- Paid parental leave
- Paid holidays
Supply Chain Team Leader
Parker Hannifin Corporation —Devens, MA
- $113,680 - $199,055 a year
- Full-time
- 6 years
- Bachelor of Science
- Analysis skills
- Paid parental leave
- Paid holidays
4d
Director, QC Automation
Bristol-Myers Squibb —Devens, MA
- $184,550 - $245,995 a year
- Email
- Hybrid work
- Travel
- Organizational skills
- Fair chance
- Paid holidays
- Disability insurance
10d

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data integrity program manager quality control jobs near worcester, ma

Data Integrity Program Manager - Quality Control

Rentschler Biopharma SE -
Milford, MA

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Job Details

$120,000 - $150,000 a year

Benefits

Health insurance
401(k)

Qualifications

Data integrity assurance
Data compliance
Data quality management
Data integrity and documentation
Laboratory information systems (LIS)
Master data management

Full Job Description

locations

Milford, MA, United States

time type

Vollzeit

posted on

Vor 18 Tagen ausgeschrieben

job requisition id

JR2776

Advancing medicine to save lives. Together.

Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.

Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.

As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.

The QC Data Integrity Program Manager identifies, implements, manages, and maintains strong Data Integrity Compliance activities within the Quality Control Department. The QC Data Integrity Program Manager, will be responsible for ensuring compliance and alignment to all relevant regulatory and internal requirements related to data integrity as well as developing training material and leading training efforts with Quality Control Staff.

Join our QC team with a quality mindset first to help make and release medicines for better lives. Our team is built on trust, respect, and integrity. The quality mindset is about operating with reliability, efficiency, and honest feedback.

Duties and Responsibilities

Implement and maintain Data Integrity compliance activities for all Quality Control systems in alignment with relevant regulatory regulations and guidelines
Represent Rentschler as the QC subject matter expert during client and regulatory inspections related to data integrity
Manage remediation efforts to identify data integrity gaps and risks and implement appropriate technical and procedural controls as required
Provide oversight of data integrity compliance for software and instrument validation lifecycle activities associated with QC computerized systems to ensure conformance to GxPs, guidance documents, applicable industry standards, and Rentschler business practices
Develop training material and lead training efforts with SMEs as it relates to Data Integrity principals and best practices
Effectively manage and execute strategic business opportunities to improve business processes
Provide day to day oversight for the governance, management and coordination of activities in QC related to Data Integrity
Work cross functionally with other departments to provide, support, guidance, and feedback on applying appropriate Data Integrity controls and best practices
Author quality system documentation such as change control, deviations, CAPAs, SOPs, work instructions

Qualifications

8+ years of relevant/relatable experience in data integrity, quality oversight of computerized system management/validation, QA compliance/regulatory and/or similar areas of focus
Must be familiar with use of electronic data management and laboratory information management
Experience in quality system management (e.g., deviations, change controls, SOPs) is preferred
Thorough knowledge of regulatory issues and the impacts on discipline
Expert knowledge on industry data integrity principles and applicable regulations such as 21 CFR Part 11, EU Annex 11, MHRA GxP Data Integrity Requirements
Advanced and deep knowledge of principles, concepts, and practices in discipline, known as a SME in that discipline, and good knowledge of principles and concepts of other relevant disciplines
Excellent organization and planning skills
Strong attention to detail and ability to adhere to standards procedures
Strong project management skills and ability to lead effective change management are desired
Strong understanding of Computerized System validation principals
Ability to drive functional, technical, and operational excellence
Working understanding of applicable QC computerized systems and how they interact such as Empower, Softmax, ViPER Analytx, and other similar software
Good understanding of the complexity, interactions, and dynamics within an international company
Experience supporting client or regulatory audits as it applies to Data Integrity

Working Conditions

Normal office working conditions: computer, phone, files, fax, copier
Working in the laboratory environment may be required when setting up LIMS master data
Personal Protective Equipment must be worn as required
Minimum travel required

Physical Requirements

PPE as required
Manual and visual dexterity required to perform laboratory and computer tasks for prolonged periods

____________________________________________________________________________
Base Pay Range

$120,000 - $150,000

Disclosure Statement

Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees’ personal and professional wellness. The salary pay range is subject to change and may be modified at any time.

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Refine Your Search

data integrity program manager quality control jobs in worcester, ma

Data Integrity Program Manager - Quality Control

Resident Chef (Sur La Table)

Digital Transformation Program Manager

Scientist, Quality Control (QC) Systems

Quality Manager

Sr. Associate, Serialization and Packaging

Manager, GMP Cleaning Program and Projects Lead

Sr Manager, Regulatory Operations

Senior Manager, Quality Assurance Material Operations, Cell Therapy

Quality Engineer II, Product

Manager, Commercial Packaging and Serialization

Sr. Internal Audit Manager

Director, Operations (Manufacturing)

Specialist, Quality Assurance Shop Floor, Cell Therapy

Sr Manager QA Technical Operations

Senior Facilities Engineer

Data Manager

Senior Manager, PMO Portfolio Management

Supply Chain Team Leader

Director, QC Automation

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