For The Candidates

Role Title:

Sr. Manager

Department/Group:

Quality Assurance

Supervisor:

Sr. Director  QA

Position Overview (Purpose of position  includes basic functions and responsibilities of job)

Assesses and communicates the state of the clinical trial and drug manufacturing activities with regard to Regulatory compliance to QA Sr. Director .

Provides review, guidance and oversight to assure company activities are in compliance with regulatory requirements, industry standards and corporate objectives/mandates.

Essential Job Responsibilities/Primary Activities (7 to 10 of the most important duties.  Each sentence should start with an action verb; i.e. completes, stimulates, supports, etc.  Each action statement should conclude with an end result.)

• Assists with planning audits and conducting external compliance audits which includes (but not limited to)  the following:  investigator sites, vendor audits (CROs, Phase I units, Clinical Labs, etc.).
• Support QA Department’s function in auditing regulatory submissions, for example NDA, eCTD, etc.
• Conduct quality review of internal documents to ensure that they meet regulatory requirements, industry standards and sponsors expectations.
• Serve as lead auditor, as assigned, in multi-auditor situations and authors audit reports which meet industry standards, the companies expectations, and require minimal input by Supervisor.
• Develops, implements and manages process for audit reports, responses, communication of significant audit observations as well as evaluate the adequacy and completeness of corrective and preventative action plans, and follow-up to closure as required.
• Accountable for reporting to QA management on the accuracy, quality and integrity of activities and processes respectively conducted and implemented within Clinical/Clinical Operations.
• Provides consultative support to internal staff on issues relating to GXP, such as GMP, GLP, GCP and computer system, compliance topics.
• Conducts peer review of internal and contracted audit reports as needed.
• Active participant to promote global harmonization, including development and technical support of global audit database and creation/review of standard operating procedures.
• Maintain up-to-date working knowledge of national regulations, guidelines, industry standards related to performance of clinical trials in North America, and may train on standard operating procedures and work instructions, GCP, GMP, compliance, auditing, etc.
• May recommend audits for QA audit plan and communicate audit results and associate relevant regulatory risk to Clinical teams.
• Present at global internal meetings.
• May assist Director with regulatory authority inspection  and other types of audits as needed.
• Performs other department duties as assigned.

Qualifications (Education/ training, experiences and skills required for the position)

• Degree in Life Sciences

Required:  Bachelors

 Preferred: 

• Minimum 5-7 years experience as an auditor in Clinical Research
• Knowledge of GXPs with emphasis on GCP experience
• Understanding of clinical development process
• Ability to travel approximately 30%

Additional Information (Critical components, special requirements, etc.)