Global QA/ra Systems Manager

2 weeks ago

Bedford, United States Werfen Full time

**Job Overview**:

- Post Date
- May 15, 2024
- Number
- ICIMS-2024-7432
- Job Function
- QA&RA
- Location
- Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States
- Country
- United States
- Shift
- 1st

**About the Position**:
**Overview**:
**Werfen**

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

**Job Summary**

Reporting to the Corporate VP QA/RA, the Global QA/RA Systems Manager is responsible for providing leadership, planning, project coordination, and management to develop a cost-effective electronic Quality Management Systems (eQMS) and harmonized QA/RA information systems while concurrently facilitating efficient operations to meet current and future business needs. Responsible for collaborating with QA/RA partners within Werfen Technology Centers and, various departments (e.g, IT), and outside vendors to develop efficient and effective processes and workflows as well as analyzing and directing all functionally related activities within the scope of the eQMS. This position is accountable for ensuring continuity and successful delivery of functional services to users throughout the organization.

**Responsibilities**:
**Key Accountabilities**
- Development of al global strategy, implementation, maintenance, operations, and optimization of the overall eQMS platforms.
- Leverage synergies between processes and workflows in the different Technology Centers and promote standardization/harmonization to the extent possible.
- Lead the Digital Board QARA meetings from the QA/RA side.
- Conduct and participate in the analysis of workflows and design of functionality and/or improvements to systems, ensuring both process and system requirements are fully identified, evaluated, tested, and implemented.
- Identify and troubleshoot system issues and work with others (IT, partners, vendors) as needed to bring to resolution.
- Work cross-functionally to understand business needs and provide actionable insights for ongoing stakeholders needs.
- Work with leadership at various Werfen technology centers to ensure timely implementation and delivery of new functionality and enhancements.
- Work with stakeholders within QARA at Werfen Technology Centers to create, update and oversee processes and workflows for eQMS systems and implement timely updates as changes occur.
- Assist with data analytics and reporting capabilities, ensuring systems are optimized to reduce manual reporting.
- Drive definition of business rules for platform governance, processes and procedures.
- Manage the eQMS supplier relationships.
- Create and execute a strategy to ensure that local eQMS stakeholders are trained.

**Networking/Key relationships**
- Corporate QA/RA Team
- Digital Board QA/RA Team
- IT Leads and teams
- Global Systems Analyst
- QA/RA leadership at Werfen Technology Centers and teams
- Key stakeholders across the organization

**Qualifications**:
**Minimum Knowledge & Experience required for the position**:

- Bachelor’s degree preferably in STEM, Information Systems, or Business
- Minimum of 5 years of directly related experience with implementing and maintaining enterprise eQMS platforms.
- Minimum of 5 years of directly related experience with QMS
- Additional Skills/Knowledge:

- IT Systems Project Management
- Language: English (fluent), Spanish (basic)

**Skills & Capabilities**:

- Well-developed leadership skills
- Strong verbal and written communication skills. Ability to present complex information in an easily consumable manner
- Ability to build relationships within Werfen departments
- Work cross-functionally to understand business needs and provide actionable insights for ongoing stakeholders needs
- Robust organizational skills
- Excellent time management skills with proven ability to meet deadlines
- Strong analytical and problem-solving skills
- Advanced understanding of database construction and configuration
- Good computer skills and proficiency with QA/RA systems
- Ability to effectively champion the project to completion through constant interaction with peers and senior leadership in a professional manner
- Ability to evaluate issues and

  • QA/ra Program Manager I

    2 weeks ago

    Bedford, United States Werfen Full time

    **Job Overview**: - Post Date - June 3, 2024 - Number - ICIMS-2024-7435 - Job Function - QA&RA - Location - Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States - Country - United States - Shift - 1st **About the Position**: **Overview**: **Werfen** *** Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona,...

  • QA/RA Program Manager I

    4 days ago

    Bedford, United States Werfen Full time

    Overview Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture...

  • QA/RA Program Manager I

    1 week ago

    Bedford, United States Werfen Full time

    Overview Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.  We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and...

  • QA Complaint Coordinator

    4 days ago

    Bedford, United States Mondo Staffing Full time

    Apply now: QA Complaint Coordinator, Hybrid opportunity local to Bedford, MA. The start date is ASAP for this long-term contract position. Job Title: QA Complaint Coordinator Location: Bedford, MA (3 days/week) Duration: 12+ months with opportunity for hire after 6 months Rate: Up to $30/hr W-2 Start Date: ASAP Job Summary: My client, a leading medical...

  • QA Complaint Coordinator

    4 days ago

    Bedford, United States Mondo Full time

    Job DescriptionJob DescriptionApply now: QA Complaint Coordinator, Hybrid opportunity local to Bedford, MA. The start date is ASAP for this long-term contract position. Job Title: QA Complaint Coordinator Location: Bedford, MA (3 days/week) Duration: 12+ months with opportunity for hire after 6 months Rate: Up to $30/hr W-2 Start Date: ASAP Job Summary: My...

  • Senior Associate, QA

    5 days ago

    Bedford, United States Tandym Group Full time

    Our client, a leader in the pharmaceutical industry, is seeking a QA Senior Associate to join their team. **This job is 5 days onsite in Bedford, MA** **W2 Only** As a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing...

  • Senior Associate, QA

    5 days ago

    Bedford, United States Tandym Group Full time

    Our client, a leader in the pharmaceutical industry, is seeking a QA Senior Associate to join their team. **This job is 5 days onsite in Bedford, MA** **W2 Only**As a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility...

  • Senior Associate, QA

    4 days ago

    Bedford, United States Tandym Group Full time

    Our client, a leader in the pharmaceutical industry, is seeking a QA Senior Associate to join their team. **This job is 5 days onsite in Bedford, MA** **W2 Only**As a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility...

  • Sr. QA Compliance Analyst

    4 days ago

    Bedford, United States Actalent Full time

    Great opportunity to get your foot in the door with one of the top Biotech companies in the Bedford, MA area! If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com Description: * Perform batch record review * Run deviations and investigations * Manage the CAPA and Change Control programs * Perform QA review...

  • Senior QA Associate

    5 days ago

    Bedford, United States Planet Pharma Full time

    As a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. The site is a multi-product facility which will be used for drug substance manufacturing, drug product manufacturing, and packaging /...

  • Senior QA Associate

    5 days ago

    Bedford, United States Planet Pharma Full time

    As a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. The site is a multi-product facility which will be used for drug substance manufacturing, drug product manufacturing, and packaging /...

  • Senior QA Associate

    4 days ago

    Bedford, United States Planet Pharma Full time

    As a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. The site is a multi-product facility which will be used for drug substance manufacturing, drug product manufacturing, and packaging /...

  • Senior QA Associate

    5 days ago

    Bedford, United States Planet Pharma Full time

    As a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. The site is a multi-product facility which will be used for drug substance manufacturing, drug product manufacturing, and packaging /...

  • Senior QA Associate

    15 hours ago

    Bedford, United States Planet Pharma Full time

    As a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. The site is a multi-product facility which will be used for drug substance manufacturing, drug product manufacturing, and packaging /...

  • Senior QA Compliance Specialist

    3 weeks ago

    Bedford, United States Anika Therapeutics Full time

    Position Scope: The Senior Quality Assurance Compliance Specialist performs compliance activities in support of production departments. Areas of responsibilities may include review of documents such as batch records, charts and logs. The Senior Compliance Specialist manages Deviations, CAPA, Change Controls, Supplier Program, performs Internal and Supplier...

  • Senior QA Compliance Specialist

    2 weeks ago

    Bedford, United States Anika Therapeutics Full time

    Position Scope: The Senior Quality Assurance Compliance Specialist performs compliance activities in support of production departments. Areas of responsibilities may include review of documents such as batch records, charts and logs. The Senior Compliance Specialist manages Deviations, CAPA, Change Controls, Supplier Program, performs Internal and Supplier...

  • QA Compliance Specialist I

    5 days ago

    Bedford, United States Anika Therapeutics Full time

    Summary of Primary Responsibilities: The Quality Assurance (QA) Compliance Specialist I performs compliance activities in support of production, engineering ensuring all activities are performed according to internal Quality System requirements, cGMP, FDA and ISO 13485 standards. Areas of responsibilities include receipt and review of documents such as...

  • QA Associate I

    5 days ago

    Bedford, United States PCI Pharma Services Full time

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary: The QA Associate I, Raw Materials is...

  • Senior QA Compliance Specialist

    3 weeks ago

    Bedford, United States Anika Full time

    Position Scope:The Senior Quality Assurance Compliance Specialist performs compliance activities in support of production departments. Areas of responsibilities may include review of documents such as batch records, charts and logs. The Senior Compliance Specialist manages Deviations, CAPA, Change Controls, Supplier Program, performs Internal and Supplier...

  • Senior QA Compliance Specialist

    3 weeks ago

    Bedford, United States Anika Full time

    Position Scope:The Senior Quality Assurance Compliance Specialist performs compliance activities in support of production departments. Areas of responsibilities may include review of documents such as batch records, charts and logs. The Senior Compliance Specialist manages Deviations, CAPA, Change Controls, Supplier Program, performs Internal and Supplier...