Senior Specialist of Quality Compliance, Standards, and Recalls

New Jersey  ‐ Onsite
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Keywords

Description

DESCRIPTION
The Senior Specialist of Quality Compliance, Standards, and Recalls will coordinate recall and market action activities for US marketed product recalls, including document creation and routing, interfacing with external service provider for recall execution, internal communication, and communication with FDA.

Responsibilities
  • Manage all aspects of US based market actions including management of recall contractor activities, development and approval of market actions letters and documentation.
  • Interface with relevant departments such as Legal, Regulatory, Medical, Safety, Logistics, etc. to ensure all relevant activities are executed in a timely manner.
  • Interface with regulators to gain agreement on market action strategy.
  • Maintain all recall documentation throughout the recall life cycle (FDA Status reports, termination and destruction requests, recall closure, and process recall invoices from the third party contractor).
  • Attend appropriate Notification to Management meetings and Market Action meetings and provide guidance on strategy.
  • Work closely with other internal departments within the Quality Operations Center and engage outside technical areas such as engineering and research and development as required.
Qualifications
  • BS or MS in pharmaceutical sciences, or equivalent degree preferred;
  • Minimum 9-13 years for manager of relevant industry experience in quality control/quality assurance, manufacturing, regulatory affairs or product development.
  • Broad experience that may include multifunctional, multi-site, or other functional experience.
  • Leadership and partnering experience on multidisciplinary teams or projects.
  • Experience working with multicultural, cross-functional work teams, in functions outside Quality Compliance, eg Operations, Regulatory, and with manufacturing sites to understand a broader perspective of their operations.
  • Demonstrated ability to make sound and effective decisions under pressure.
  • Experience in Quality Compliance functions.
  • Exposure to Regulatory inspections including interactions with Regulatory Agency representatives and responding to Regulatory Agency observations.
  • Project management skills.
  • Excellent verbal and written communication skills and strong interpersonal skills.
  • Ability to travel frequently: approximately 10%
  • Knowledge of Manufacturing environment and processes and interdepartmental linkages.
  • Experience in global regulatory environment and associated processes.
  • Understanding the Quality Organization Roles and Responsibilities.
  • Good knowledge of cGMP.
  • Demonstrated problem solving and negotiation skills.
  • MS Office expertise.
  • Must be able to work with and retain information of a confidential nature.

SKILLS
MS Office

Synectics is an Equal Opportunity Employer.

Start date
n.a
From
Generic Network
Published at
29.11.2011
Project ID:
274548
Contract type
Freelance
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