Associate Director, QA Compliance

Job Locations US-MA-Framingham
Job ID
2020-1391
# of Openings
1
Category
Quality Assurance/Quality Control
Type
Full Time
Company
LFB USA

Overview

The QA Associate Director, Compliance supports the optimization of the strategic direction for quality strategies, systems, policies, and procedures and manages the compliance training program which includes the implementation, optimization, maintenance, and assessment of company-wide training and management of support staff for a role-based electronically tracked training program as needed.  In addition, this position will manage oversight for the vendor management program including maintenance of the Approved Supplier List, annual vendor reviews, and support companywide efforts to maintain acceptable levels of compliance with internal procedures, corporate requirements, and applicable regulations (i.e. FDA, EMA, etc. as applicable).  The position will foster a collaborative environment and work closely with affected departments to ensure compliance by providing training modules, supporting inspections, assisting with internal audit program, product quality reviews, and key performance indicator trending.

Responsibilities

  • Manage company-wide electronic training system by implementing, optimizing, maintaining role-based training curricula, employee training files, and on-going assessment program.
  • Ensure completion of departmental employee year-end training reviews.
  • Support compliance training through creation and presentation of training modules for GXP compliance and by providing on-boarding training as needed.
  • Support regulatory inspections and serve as lead SME for role-based training program. Support other departments with the preparation of responses, as needed.
  • Lead oversight for the vendor management/supplier approval program including maintenance of the Approved Supplier List, management of departmental annual vendor reviews/updates, and management for creation/response to vendor questionnaires.
  • Assist with performance of internal audits and tracking of responses to ensure progress.
  • Assist with tracking of Quality metrics, key performance indicators, risks, and data for product quality reviews, Corporate Quality Policies, and QMRC and implementation/validation efforts for CFR part 21 compliant tracking software applications.
  • Support the inspection readiness program and support the execution of regulatory audits.
  • Author and revise compliance documents, training courses, and training assessments and perform QA review and approval of documents as needed.
  • Support management of quality systems for exceptions (i.e. Deviations, CAPAs, Change Controls, and OOS investigations).
  • Support Quality Operations by performing compliance review for data used for regulatory filings, validations, campaign summary reports, risk management reports, investigation, and technical reports as needed and assisting with Quality Compliance run meetings as needed.
  • Support Quality Control Equipment and System and test method validations as required.
  • Train and mentor coworkers as needed.
  • Perform additional tasks associated with Quality Compliance and Quality Operations, as needed.

Qualifications

BS, MS, or equivalent pharmaceutical/biotechnology industry experience (15+ years) with at least 10 years in a Quality function. Must be proficient in EDMS and Training Mgmt. software with a specialty in implementation and management of role-based training curricula and staff.  Must have extensive experience in vendor management and the management/performance of internal audits.  CBA/CQA certification preferred.  Must be a dynamic, hands-on manager with a clear practical understanding of GXPs, the ability to support regulatory inspections, and to assist with the creation of training materials and modules.  Experience with product quality reviews, the management of key performance indicators, and review of validations is desired. Excellent written and verbal communication skills and proficiency in Microsoft software applications. Strong Communication and listening skills required. Ability to work and communicate with all levels within the organization in a constructive and positive manner.

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