Experience:
1-3 years of experience
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Employment Type:
Full time
Posted:
8/29/2018
Job Category:
Software Development
Industry:
Other
Field Quality Manager
(This job is no longer available)
Octapharma Plasma, Inc. | Hoboken, NJ
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Job Description

Quality – Regulatory

We are seeking a Field Quality Manager to join our growing biopharmaceutical company. Reporting into the Director of Field Quality, this position promotes quality standards for the plasma centers and ensures that corporate quality policies and procedures are followed by center personnel. 

Additional responsibilities of the Field Quality Manager role include:

  • Serves as a quality liaison between Field Quality Director and center operations in matters of quality.  Ensure consistent compliance with FDA, EU, OSHA, PPTA, customer and other regulatory authorities.  Provides support to field operations in achieving company goals while complying with regulatory requirements and driving quality excellence.
  • Develops and fosters a philosophy of continuous improvement in all centers. Implements and consistently promotes the philosophy that compliance in quality, safety and training is essential to successful operations.
  • Represents corporate during regulatory audits/inspections and provides responsive leadership during the course of the audit.
  • Interacts with Donor Center and appropriate OPI personnel to facilitate corrective and preventative actions for inspection findings.
  • Assists Donor Centers in preparing for audits and provides direction in development of written responses.
  • Support Regional Directors in development of CAPAs for internal and external audits. 
  • Analyzes deviation and audit tracking and trending data for systemic issues and develops effective preventive actions.
  • Prepares, edits, and revises standard operating procedures and policies based on needed process improvements and/or changes in regulatory requirements.
  • Drives Communication up and down the organization. Builds partnerships that support and encourage participation and innovation in creating problem solving strategies that enable the region to meet corporate objectives.
  • Conducts regularly scheduled meetings with center quality staff to continuously develop, monitor and evaluate quality staff training and development.
  • Support the center's ongoing quality training and education through routine training sessions.

Qualified candidates of this role must offer a minimum of three years’ experience a biologics, drug manufacturing, medical device or FDA regulated facility. You must offer strong organizational skills, attention to detail and excellent writing skills.

Other requirements of the Field Quality Manager role include:

  • Bachelor’s degree in one of the allied sciences (chemistry, biology, medical technology) is preferred. Other combinations of education and experience may be considered. 
  • 2+ years’ supervisory experience strongly preferred.
  • CQA (Certified Quality Auditor) certification highly desired.
  • Demonstrated expertise and knowledge of cGMPs, FDA regulations, SOP implementation as well as an understanding of quality control principles and QA audit functions.
  • Demonstrated decision-making ability and ability to positively influence/manage people.
  • Ability to solve practical problems and deal with a variety of concrete variables. 
  • Ability to operate computer software including Microsoft Office Suite.
  • Ability to travel approximately 75% of time.

About Octapharma Plasma, Inc.

We believe the growth and success of each of our employees is an important part of the continued growth and success of our company. We create a workplace known for teamwork and recognition based on the following values: Customer Focus Leadership Integrity Team Spirit Self Respect Respect for Others Life Balance Safety