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Associate Director, Quality Compliance and Oversight - Drug Safety. Job in Cambridge, Massachusetts, United States in Biogen. Nelest.com
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Associate Director, Quality Compliance and Oversight - Drug Safety

col-narrow-left   

Job ID:

23092

Location:

Cambridge, MA 

Job function:

Business Development, Project Management
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Associate Director, Quality Compliance and Oversight - Drug Safety

Job Description:

The Associate Director, Quality Compliance and Oversight provides direct supervision to the Quality and Compliance Oversight Managers and Associates and is responsible for overseeing the tracking, management and reporting of quality and compliance metrics across the SABR organization and establishing processes and tools to drive continuous quality improvement. Key responsibilities include overseeing periodic reviews of quality and compliance KPIs and metrics and managing the QC of root cause analysis and trending of critical quality related issues such as Late Case Investigations and overseeing the late case investigation process. The Quality and Compliance Oversight Associate Director may also support PV Regulatory Intelligence activities.

1. Provide direct supervision and management of Quality and Compliance Oversight Associates team (including mentoring)

2. Oversee the tracking and management of SABR quality and compliance metrics as well as the development of quality dashboards / reports for dissemination to Senior Leadership and partners

3. Managing the QC of the following activities:
- Root cause analysis of critical quality related issues such as Late Case Investigations
- Trending of critical quality related issues such as Late Case Investigations

4. Manage and oversee the late case investigation process

5. Lead the development and implementation of processes and tools to drive continuous quality improvement of data, processes or products across SABR

6. Oversee the execution of PV Regulatory Intelligence activities*
- Support the development of the intelligence gathering process and tools, monitor and capture PV regulatory intelligence
- Coordinate evaluation of proposed, new, emerging regulation / requirements / policy changes
- Attend regulatory intelligence meetings / committees as required

* Only a subset of Quality and Compliance Oversight team will support this activity

*LI-RD1

Job Requirements:

Qualifications
- 7+ years experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences
- Minimum of 3-4 years management and / or project management
- Knowledge of Post-Marketing and Clinical Trial Pharmacovigilance regulations
- Direct experience in GCP compliant quality systems
- Regulatory affairs, quality assurance or clinical departments experience is preferred The employee must have strong knowledge of pharmaceutical R&D regulatory affairs, project management skills, drug safety knowledge, meeting facilitation and documentation skills. The position also requires leadership skills that provide solutions to complex problems across SABR functional areas, working closely with all stakeholders. EducationMaster's level degree (or Bachelor's Degree with relevant experience) in medical or life sciences or the equivalent experience About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

Founded in 1978, Biogen is the world's oldest independent biotechnology company. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.

Zip Code:

02142

Company Info
Biogen

Cambridge, MA, United States

Phone: +1 781-464-3260, +1 781-464-3260
Web Site: www.biogene.com

Company Profile

Company Info


Biogen
Cambridge, MA, United States
Phone: +1 781-464-3260, +1 781-464-3260
Web Site: www.biogene.com

Associate Director, Quality Compliance and Oversight - Drug Safety

col-narrow-left   

Job ID:

23092

Location:

Cambridge, MA 

Job function:

Business Development, Project Management
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Associate Director, Quality Compliance and Oversight - Drug Safety

Job Description:

The Associate Director, Quality Compliance and Oversight provides direct supervision to the Quality and Compliance Oversight Managers and Associates and is responsible for overseeing the tracking, management and reporting of quality and compliance metrics across the SABR organization and establishing processes and tools to drive continuous quality improvement. Key responsibilities include overseeing periodic reviews of quality and compliance KPIs and metrics and managing the QC of root cause analysis and trending of critical quality related issues such as Late Case Investigations and overseeing the late case investigation process. The Quality and Compliance Oversight Associate Director may also support PV Regulatory Intelligence activities.

1. Provide direct supervision and management of Quality and Compliance Oversight Associates team (including mentoring)

2. Oversee the tracking and management of SABR quality and compliance metrics as well as the development of quality dashboards / reports for dissemination to Senior Leadership and partners

3. Managing the QC of the following activities:
- Root cause analysis of critical quality related issues such as Late Case Investigations
- Trending of critical quality related issues such as Late Case Investigations

4. Manage and oversee the late case investigation process

5. Lead the development and implementation of processes and tools to drive continuous quality improvement of data, processes or products across SABR

6. Oversee the execution of PV Regulatory Intelligence activities*
- Support the development of the intelligence gathering process and tools, monitor and capture PV regulatory intelligence
- Coordinate evaluation of proposed, new, emerging regulation / requirements / policy changes
- Attend regulatory intelligence meetings / committees as required

* Only a subset of Quality and Compliance Oversight team will support this activity

*LI-RD1

Job Requirements:

Qualifications
- 7+ years experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences
- Minimum of 3-4 years management and / or project management
- Knowledge of Post-Marketing and Clinical Trial Pharmacovigilance regulations
- Direct experience in GCP compliant quality systems
- Regulatory affairs, quality assurance or clinical departments experience is preferred The employee must have strong knowledge of pharmaceutical R&D regulatory affairs, project management skills, drug safety knowledge, meeting facilitation and documentation skills. The position also requires leadership skills that provide solutions to complex problems across SABR functional areas, working closely with all stakeholders. EducationMaster's level degree (or Bachelor's Degree with relevant experience) in medical or life sciences or the equivalent experience About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

Founded in 1978, Biogen is the world's oldest independent biotechnology company. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.

Zip Code:

02142
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