Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Director Of Quality Assurance And Quality Control

Expired Job

Cybercoders Bensalem Township , PA 19020

Posted 4 months ago

Minimum Required Skills:
Quality Assurance, Quality Control, Pharmaceutical, Early Phase Product Development (Phase I/II), Large Molecule Products, Small Molecule Products, Antibody Drug Conjugates (ADCs), Audits, Validation, GMP

Based just outside of NE Philadelphia near Bensalem, we're an emerging CDMO (contract development and manufacturing organization). If you are a Director of Quality Assurance and Quality Control looking for a fast-paced, pharmaceutical / biotech cGMP manufacturing environment where you will have the opportunity for huge growth, please read on! If not, know anyone? Feel free to share my info!

What's In It for You

We offer full, generous benefits including medical, dental, vision, life, 401K contributions, PTO, holidays, and more!

What You Will Be Doing

The Director of Quality Assurance and Quality Control will lead quality operations for:

  • Early-phase GMP manufacturing of novel cytotoxic

  • Antibody drug conjugate (ADC) compounds

  • Phase 1-2 clinical trials

Including investigations, validation, technical transfer of test methods, review of batch records, and more.

What You Need for this Position

REQUIRED:

  • Life sciences degree or equivalent experience

  • 8+ years' managing GMP quality (ideally both QA and QC) in the pharmaceutical industry

  • 2+ years' experience of QA and QC in for small molecules products and / or biologics

  • A strong background in GMP and good documentation skills

  • Skills to accurately and precisely document and record laboratory activities, results, and conclusions

PREFERRED:

  • Experience working directly for a CDMO / CMO/ or CRO

  • Experience of Antibody Drug Conjugates (ADCs) or other conjugated products

  • Analytical method development such as HPLC and LC/MS

  • Strong Microsoft Office skills, including ExcelSo, if you are interested in this Director of Quality Assurance and Quality Control opportunity, please apply today!

Applicants must be authorized to work in the U.S.Please apply directly to by clicking 'Click Here to Apply' with your Word resume!

Looking forward to receiving your resume and going over the position in more detail with you.

  • Not a fit for this position? Click the link at the bottom of this email to search all of our open positions.

Looking forward to receiving your resume!

CyberCoders

CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work

  • In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Copyright 1999 - 2018 . CyberCoders, Inc. All rights reserved.

Skills:
Quality Assurance, Quality Control, Pharmaceutical, Early Phase Product Development (Phase I/II), Large Molecule Products, Small Molecule Products, Antibody Drug Conjugates (ADCs), Audits, Validation, GMP - Quality Assurance, Quality Control, Pharmaceutical, Early Phase Product Development (Phase I/II), Large Molecule Products, Small Molecule Products, Antibody Drug Conjugates (ADCs), Audits, Validation, GMP
Permanent
Full-time, Employee


upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
QA Manager (R1051863)

Iqvia Holdings Inc

Posted 1 week ago

VIEW JOBS 1/8/2019 12:00:00 AM 2019-04-08T00:00 Job Description Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. Position Manager, QA Department Quality & Compliance Position Summary The Quality Manager is responsible for managing the ACUTA Quality Management System (QMS). In other words, he/she must manage all ACUTA company-wide, quality policies, procedures, processes, programs, and practices, to assure the company of continuous conformance with appropriate standards and regulations. This a very critical role within the organization as the Quality Manager will be the "Go To" person for answers related to quality, covering product specifications, supplier requirements, testing, verification, audits, corrective actions, non-conformances, benchmarking and the voice of the customer. Duties and Responsibilities * Quality Standards - Ensure that processes needed for the Quality Management System (QMS) are established, implemented and maintained. Manage and control documents and records all throughout the company. * Quality Project Management – responsible for managing corrective action, process improvement, and auditing projects. * Business Process Documentation - must be able to understand, comply, and improve established company policies and procedures. Developing standard work, policies, procedures, job aids, and business process communications are a part of the job. * Document Control - knowledge of the Quality documentation process, Document Control practices, and managing documents, records, forms, and work instructions is vital to maintaining company's compliance program. * Quality Communications - Explaining business process compliance to others. Asking questions, collecting business process information, and working with others in a positive and collaborative manner. * Quality Auditing - performs quality audits. Clearly understanding the compliance requirements, collecting objective evidence, and writing up audit reports ensure the quality management system is operating effectively. * Problem Solving - solves problems, typically in situations where general standardization should exist, but may not be operating effectively. * Team Player - is involved in teams and meetings at every level of the organization. Management reviews, material reviews, supplier reviews, corrective action reviews, process improvement teams, audits, customer visits and strategy discussions. Detailed Responsibilities * Report to management on the performance of the QMS and any need for improvement. * Ensure the promotion of awareness of customer requirements throughout the organization. * Ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of the QMS. * Ensure that records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records. * Ensure that the performance of the QMS is reviewed at planned intervals to ensure its continuing suitability, adequacy and effectiveness. This review means assessing opportunities for improvement and the need for changes to the QMS. * Ensure that Quality Objectives are set by top management for measuring the performance of the QMS and that these are regularly reviewed. * Ensure that all new staff are inducted into the requirements of the QMS related to their own roles and responsibilities. Provide update training as necessary. * Ensure that all suppliers used by the organization are selected, evaluated and reevaluated and that records of this assessment are maintained. * Ensure that an internal audit program is adopted to verify that the QMS conforms to planned arrangements, QMS arrangements and is effectively implemented and maintained. Ensure that appropriate action is taken when this is not the case. * Analyze data on the effectiveness of the QMS and evaluate where continual improvements of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. * Coordinate continual improvements of the QMS, ensuring that evidence of corrective and preventive actions taken are recorded and reviewed. * Responsible for implementing and managing the Quality review and oversight of software products developed by ACUTA. * Implement & monitor quality improvements in products and services. * Monitor performance measures that include those measurements critical to customer satisfaction and compliance. * Responsible for attending and hosting customer audits and follow-up on the findings with a plan of remediation. Qualifications The Quality Manager is expected to have 8 or more years of overall quality management experience, with a good understanding of the pharmaceutical industry regulations. Some of the required technical skills and abilities include a working knowledge of: * Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement. * Understanding of the Life Sciences industry and the drug lifecycle process. * Knowledge of various regulatory submissions and recognize the differences. * Understands the needs, guidelines and complexities of electronic publishing. * Extensive experience auditing software vendors and hosting customer audits. * Understanding and application of domestic and international regulatory requirements. * Outstanding communication skills (interpersonal, verbal and written). * Proven track record of industry success. * Strong leadership and management skills. * Excellent teamwork and collaboration skills. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled' We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™ Job ID: R1051863 Apply Now Not ready to Apply? Check Out Similar Jobs * Quality Assurance Jobs * Quality Manager Jobs * Jobs in Plymouth Meeting, Pennsylvania * Quality Assurance Jobs Plymouth Meeting, Pennsylvania Iqvia Holdings Inc Bensalem PA

Director Of Quality Assurance And Quality Control

Expired Job

Cybercoders