Welcome to Simply Hired!

Like what you see here? Check out more Industrial Production Managers like this one.

Show Me More

Manager Clinical Quality Assurance

Apply Now

Company: Fresenius

Location: Waltham, MA

Date Posted: March 6, 2014

Source: Fresenius Medical Care

PURPOSE AND SCOPE:

Supports FMCNA’s mission, vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements.

Responsible for development, implementation and oversight of clinical trial systems and associated documentation for all phases of clinical development. Provide leadership in cross-functional teams to identify and address quality risk areas related to clinical trial research. Lead the development of the Quality System relating to GCP while supporting Fresenius Medical Care NA site and clinical site operations. Provides guidance in the development of corrective and preventative action (CAPA) plans following identification of compliance issues/concerns; monitors progress to ensure successful completion/implementation of CAPAs. Serves as an expert resource for quality questions and issues of high complexity and impact. Partners with various internal and external groups to quickly analyze problems, identify and communicate options, and recommend and assist with development of ...

PURPOSE AND SCOPE:

Supports FMCNA’s mission, vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements.

Responsible for development, implementation and oversight of clinical trial systems and associated documentation for all phases of clinical development. Provide leadership in cross-functional teams to identify and address quality risk areas related to clinical trial research. Lead the development of the Quality System relating to GCP while supporting Fresenius Medical Care NA site and clinical site operations. Provides guidance in the development of corrective and preventative action (CAPA) plans following identification of compliance issues/concerns; monitors progress to ensure successful completion/implementation of CAPAs. Serves as an expert resource for quality questions and issues of high complexity and impact. Partners with various internal and external groups to quickly analyze problems, identify and communicate options, and recommend and assist with development of appropriate solutions. Assists with inspection activities (preparation, conduct, and responses) for clinical regulatory inspections internally and externally at investigator sites, when appropriate. Develops and provides GCP and related training in support of compliance systems and quality improvement initiatives with Fresenius Medical Care NA.

CUSTOMER SERVICE:

* Responsible for driving the FMCNA culture through values and customer service standards.

* Accountable for outstanding customer service to all external and internal customers.

* Develops and maintains effective relationships through effective and timely communication.

* Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner.

PRINCIPAL RESPONSIBILITIES AND DUTIES:

* Develops and implements plan for generation of Clinical Quality SOPs relating to GCP in alignment with the Quality System.

* Acts as key Clinical QA representative to clinical sub-teams to provide leadership and guidance to Fresenius Medical Care NA clinical team regarding GCP and regulatory compliance.

* Reviews and approves clinical documents that will be submitted to regulatory authorities (i.e., CSRs, clinical protocols, IRBs, NDAs)

* Reviews and approves clinical operations, records management and regulatory affairs SOPs.

* Coordinates internal audits of Fresenius Medical Care NA clinical and safety database, SAE tracking and records management; perform audit of clinical study reports and audit clinical central files for FDA and ICH compliance.

* Coordinates vendor audits, including central imaging, central laboratories, central ECG reads, IVBS, Safety, Pharmacovigilence, clinical CROs, as well as clinical data management CROs including EDC vendors, if required.

* Assists in establishing and conducting inspectional readiness training for Fresenius Medical Care NA clinical team.

* Tracks and reports monthly progress regarding closure of outstanding audit findings

* Provides leadership and coaching to all direct reports and partners with human resources on employee matters.

* Other duties as assigned.

EDUCATION:
Bachelor's or Master’s degree in a scientific discipline or equivalent with 5-8 years pharmaceutical industry experience with clinical compliance, clinical QA and/or clinical operations background, GCP auditing, and participation in regulatory agency inspections. RN experience desirable.

EXPERIENCE AND REQUIRED SKILLS:

· Must have the ability to apply quality system concepts to daily GxP operations. Strong understanding of applicable regulations (GCP, FDA and ICH guidelines, etc.)

· Knowledgeable in advocating proactive measures to ensure GxP compliance and ability to consistently demonstrate the value of GxP QA to internal and external customers

· Outstanding quality skills, attention to detail and a clear comprehension of the regulatory basis and risk to the Company associated with audit findings

· Expertise in reviewing, modifying and writing Standard Operating Procedures (SOPs)

· Ability to work both independently with direction and within project teams to attain team goals

· Excellent interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and consulting staff at all levels of the Fresenius Medical Care NA organization, as well as vendors and clinical sites

*LI-SG1

SHARE

Apply Now Current Employee?

Show more

Other jobs you might like

  • Field Quality Control Manager

    NEW

    Absolute Resource Associates

    - Portsmouth, NH

    Absolute Resource Associates is seeking a Quality Control Manager for our contracts with the Navy in the Northeast. The Quality Control Manager will be responsible for the on site...

    1 day ago from Absolute Resource Associates
  • Manager, Quality AssuranceUnited States

    Thermo Fisher Scientific

    - Franklin, MA

    Posting date: August 14, 2014 Position Summary: Experienced Quality Leader needed to drive the day-to-day GMP Quality Control and Quality Assurance activities. * Assessment for...

    6 days ago from Thermo Fisher Scientific Inc
  • Director Quality

    Genzyme

    - Allston, MA

    Director Quality-70062140-33717 Description Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases...

    30+ days ago from Genzyme
  • Quality Manager - IT

    Tiaa-cref

    - Boston, MA

    Job Description TIAA-CREF Retirement & Individual Technology team is responsible for designing, building and maintaining all applications supporting recordkeeping, middle and back...

    16 days ago from TIAA CREF
  • Project Mgr. Quality & Safety

    Lahey Health

    - Burlington, MA

    1) Supports the work of the Department of Quality Performance & Innovation . 2) Participates and supports in departmental and/or hospital-wide committees, teams and/or task forces...

    30+ days ago from Lahey Health
  • Director of Quality & Performance Improvement (9637)

    Metrowest Medical Center

    - Massachusetts

    Office environment, constant use of computer and telephone. The above statements are only meant to be a representative summary of the major duties and responsibilities performed...

    30+ days ago from MetroWest Medical Center
  • Quality Development Manager

    InterSystems

    - Cambridge, MA

    Overview: InterSystems develops advanced software technologies that enable breakthroughs. With a passion for excellence and a focus on client success, InterSystems provides data...

    13 days ago from IHispano
  • Quality Assurance Manager, GSN.com

    Gsn Games

    - Waltham, MA

    Location: Waltham, MA GSN Games’s games are played tens of millions of times each day making it one of the most popular casual gaming companies in the US. In order to keep pushing...

    13 days ago from TheLadders.com
  • Director of Quality Control & Assurance

    NEW

    Nw Recruiters

    - Boston, MA

    DIRECTOR OF QUALITY CONTROL & ASSURANCE   ...

    2 days ago from ZipRecruiter
  • Supplier Quality Manager

    Sullivan and Cogliano

    - Peabody, MA

    Direct hire position available immediately for a Supplier Quality Manager in Peabody, MA! Automotive industry experience a definite plus! Resumes in MS Word please! POSITION...

    7 days ago from Dice

Show Me More

Were you satisfied with these results? Yes | No
Thank you for your feedback!