Clinical QA Specialist (GCP) - Newark, CA | Biospace
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Clinical QA Specialist (GCP)

Depomed, Inc.

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Location:
Newark, CA
Posted Date:
12/4/2016
Position Type:
Full time
Job Code:
778XX
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

City Newark
State California [CA]
Title Clinical QA Specialist (GCP)
Job ID 778XX
Date Added 11/1/2016
Department Clinical Operations

Description

JOB SUMMARY
The Clinical QA Specialist (GCP) will be responsible for ensuring the activities performed or outsourced by the Clinical Affairs department are in accordance with GCP, International Conference of Harmonization (ICH) guidelines, federal and international regulations and Depomed SOPs. Will work closely with cross-functional representatives, including Clinical Operations, Biostatistics, Data Management, Regulatory/QA, Drug Safety, CMC, etc. to ensure regulatory and company compliance. Audit clinical investigative sites and other clinical research third party vendors as needed to support compliance objectives for the Clinical Affairs department.

ESSENTIAL JOB FUNCTIONS

Primary Responsibilities:
• Perform vendor qualifications and ensure quality oversight of vendors throughout term of service.
• Plans and leads GCP audits of clinical sites, vendors and trial master files to ensure compliance to the Code of Federal Regulations, ICH, applicable regulations and company SOPs.
• Responsible for initiating and managing corrective action plans for the department.
• Reviews and identifies gaps in department SOPs.
• Performs a quality review of clinical documents including but not limited to protocols, clinical study reports and investigator brochures.
• Ensures compliance of clinical development activities with GCP, ICH guidelines, federal and international regulations and Depomed SOPs.
• Assists in investigative site preparation for regulatory agency visits.
• Provides training to the Clinical Affairs team members in GCP and ICH guidelines.
• Performs internal audits of the Clinical Affairs department.

ADDITIONAL RESPONSIBILITIES/DUTIES
• Other duties as assigned.

Requirements

EDUCATION AND EXPERIENCE
• Bachelor's degree preferably in a science or healthcare field.
• A minimum of 3-5 years of direct experience in GCP QA activities.
• Extensive knowledge of GCP, ICH guidelines and federal regulations as it relates to clinical research.


SKILLS AND ABILITIES
• Demonstrated computer skills (e.g. MS Office, MS Project, and MS PowerPoint).
• Organized, detail-oriented and able to work independently with minimum supervision but also work collaboratively
• Sense of urgency in completing assigned tasks
• Willing and able to learn new skills to meet changing needs of the organization
• Analytical
• Excellent teamwork and collaboration skills
• Effective process and project management skills
• Outstanding written and verbal communication skills
• Knowledge of clinical study conduct
• Ability to multi-task


DEPOMED COMPETENCIES INCLUDE
• Integrity and respect: Honest, trustworthy and accountable. Ensures all activities performed are done ethically and according to Depomed procedures and regulatory guidance. Shows respect for all team members (internal and external).
• Decisions and Judgment: independently completing assigned tasks by gathering relevant information systematically and considering a broad range of issues or factors when making decisions.
• Accountability: Assumes personal ownership and accountability for business results and solutions. Organizes work based on company/department goals. Develops alternative strategies when confronted with obstacles. Plans and organizes work so that timelines are met or exceeded.
• Agility: Able to quickly adapt to study changes. Communicates and implements changes in a positive manner.
• Teamwork and Collaboration: Expresses ideas and information effectively and constructively. Provides accurate and timely information to others within the department and across functional groups. Demonstrates attention to and understanding of others’ comments, questions, and views.


PHYSICAL/MENTAL DEMANDS
• Sitting – 80%
• Standing/ walking - 20%
• Travel up to 20-40% (domestically and internationally)
• Ability to carry items weighing less than 10 pounds
• Ability to hear what clients are saying in a normal conversation
• When not traveling maintain in-office, regular work hours to facilitate interactions with other employees
• Repetitive motion: Substantial movements of the wrists, hands, and or fingers for sustained periods of time. Approximately 6-hours of keyboarding per day.
• Visual Requirements: Able to see and read PC screens and read fine print.

About Us

Depomed, Inc. is a specialty pharmaceutical company focused on developing and commercializing products to treat pain and other central nervous system conditions. Founded in 1995, Depomed has successfully executed on strategy of acquiring, integrating and growing differentiated therapeutic products and building each into a strong market presence. The result is a broad portfolio of pain and neurology specialty pharmaceuticals currently comprised of five FDA-approved products. These include Gralise® for the management of Postherpetic Neuralgia (PHN), Cambia® for the acute treatment of migraine attacks, Zipsor® for the relief of mild to moderate acute pain, Lazanda® for the management of breakthrough pain in cancer patients and our most recent addition, the company’s flagship asset, the NUCYNTA® franchise.

Acquired in April 2015 and re-launched in June 2015, the NUCYNTA franchise includes NUCYNTA® ER for the extended management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN) and NUCYNTA® for immediate management of moderate to severe acute pain in adults.


Depomed also has successfully developed and licensed its unique drug-delivery technology, Acuform®. This patented oral-delivery technology allows for the targeted, extended release of pharmaceutical compounds into the upper gastrointestinal tract. The company’s Acuform technology is currently being used in four marketed drugs, including Gralise.

Depomed’s successful execution on strategy and has resulted in solid product revenue growth over the past three years. Located in Newark, California in the East Bay of San Francisco, Depomed is listed on the NASDAQ market under the ticker DEPO and employs approximately 500 people, of which approximately 350 are part of the Commercial organization.


Depomed is an AA/EEO/Veterans/Disabled employer.