Associate Director Development QA, Quality Compliance

Employer
Celgene
Location
Summit, NJ, US
Posted
Sep 11, 2018
Ref
1803129
Required Education
Bachelors Degree
Position Type
Full time
Other Locations:US- NJ- Summit West

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

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Title: Associate Director Development QA, Quality Compliance

Version: 1.0

Effective Date:

Position

Associate Director Development QA, Quality Compliance

Manager

Executive Director, Quality Operations, Development

Prerequisites (As

Applicable)

B.S. degree required, advanced degree preferred. Minimum 10 years

Quality Control and/or Quality Assurance experience in a pharmaceutical company or other related industry

Location

Summit, NJ

1. PURPOSE AND SCOPE OF POSITION:

This position is responsible for management of compliance activities for Quality Operations, Development QA in accordance with Celgene policies, standards, procedures and Global cGMPs. Functional responsibilities for the incumbent include hosting and management of regulatory inspections for Development GMP/GDP facilities and corporate audits, management of the internal inspection readiness program, management of emerging regulations and systematic evaluation of new requirements, oversight for trending of quality compliance metrics.

2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

• Inspections
  • Manages, hosts and facilitates Celgene Health Authority inspections for GMP Development facilities in Summit West. and responsible for generating applicable responses. Interacts with HA officials to convey the compliance level of quality systems during inspections and through direct communication with HA officials.
  • Supports the responsible Development QA Vendor Quality Manager (VQM) in the preparation and hosting of regulatory authorities' inspections of Vendor manufacturing sites. Acts as the Development QA representative and SME for relevant topics during authorities' inspections.
  • Responsible for hosting the internal/external GMP audits of GMP development areas overseen by Dev QA including the yearly internal audit plans, and the follow up and the implementation of the internal audit CAPAs.
  • Responsible for supporting audit of other functions where Development QA processes are impacted. Functions as the Development QA representative for presenting Development QA SOP based processes and formulating responses to audit observations.
  • Responsible for ensuring and/or conducting quarterly quality checks (of Development GMP functions within Summit West site) as per local procedural requirements

Withdrawals
  • Responsible for leading Clinical Material Withdrawal Process for Dev QA. Responsible for Coordinating Mock Withdrawal process for site and acts as site representative to support Mock Withdrawal process. Coordinates the post withdrawal lessons learnt and implementing of improvements to the Clinical Material Withdrawal process.

Quality Management Systems
  • Oversees the Compliance and implementation of Development QA's Quality Management System to ensure Change controls, Deviations, Investigations, Customer Complaints, CAPAs and Documentation changes are reviewed and approved in a compliant and timely manner for GMP development areas overseen by Development QA.
  • Acts as site SME for Quality Operations Development QA training curricula management and Super User for Quality Management enterprise systems for Change Controls, Deviations, Product Quality Complaints and Training.
  • Will be the representative for Development QA on the Global Data Governance and Data Integrity Initiative
  • As required, performs Quality Operations review and approval for Development QA change controls, deviations, CAPAs and documentation changes.
  • Contributes to the improvement of existing processes and the development of new processes or sub-processes related to the Quality Management System. Will represent Development QA on the GMP/GDO Compliance Community of Practice forum

Metrics
  • Compiles and coordinates Development Quality Operations site metrics for presentation to Development QA management via Management Review process. Manages and coordinates site Management Review meetings.

Training
  • Maintains Job Descriptions for Development QA department personnel.
  • Oversees the training of personnel in Development QA by ensuring appropriateness of training assignment and timely completion of training.
  • Performs annual curriculum reviews for Development QA.

Regulations & Submissions
  • Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.
  • Oversees assessment and compliance to new Emerging Global Regulations by ensuring timely communication within Development QA and to GMP Development areas overseen by Development QA. Regularly follows up both within Development QA and with Stakeholders to ensure assessment and implementation of applicable new Regulations.


• Excellent verbal and written communication skills.

3. EDUCATION AND EXPERIENCE

• B.S. degree required, advanced degree preferred.

• Minimum 10 years of experience in the pharmaceutical industry is required.

• Thorough understanding of cGMPs and FDA regulatory requirements.

• Experience leading internal audits and health authority inspections.

• Solid understanding of aseptic manufacturing processes and QC testing in the pharmaceutical industry.

• Work independently, yet effectively in a team environment.

• Strong attention to detail, excellent verbal and written communication skills.

• Excellent investigational and QA problem solving skills.

• Analytical mind, ability to assess new products or new projects in order to define and implement the appropriate QA action plan.

4. WORKING CONDITIONS: (US Only)

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

5. DEFINITIONS AND ABBREVIATIONS (As Applicable)

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

This is the end of the Official Use document

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.