Quality Assurance Manager

Integrated Resources, Inc ( IRI ); Exton (Chester County); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player in pharmaceutical manufacturing is seeking a Delivery Lead for Quality Assurance. This pivotal role focuses on maintaining and enhancing Quality Systems to ensure compliance with regulatory standards and GMPs. The ideal candidate will possess a strong background in Quality Systems and IT applications, along with excellent communication and project management skills. You'll collaborate with various teams to promote quality awareness and oversee compliance across multiple sites. If you're looking for a challenging opportunity to make a significant impact in a regulated environment, this position is perfect for you.

Qualifications

• 5-7 years of experience with Quality Systems and compliance.
• Proficiency in Quality Systems IT applications and CGMPs.

Responsibilities

• Ensure compliance with GMP and Data Integrity requirements.
• Support audits and manage Quality Systems processes.

Skills

Attention to Detail

Communication Skills

Project Management

Problem Anticipation

Process Orientation

Education

Bachelor’s degree in a science-related discipline

Tools

TrackWise

Documentum

MS Word

MS Excel

MS Project

MS Visio

Job description

Delivery Lead - Recruitment at Integrated Resources, Inc ( IRI )

DESCRIPTION:

This position is responsible for maintaining and improving Quality Systems for the Client Americas Region to ensure ongoing compliance with applicable compendia, GMP’s, and Regulatory guidance. The Quality Systems include quality risk management, documentation, global and local auditing, health authority inspection management, training, event management (deviations, complaints, CAPA), and change control (global and local). The role will interface with Quality System personnel in other Client sites.

The person in this position will serve as a subject matter expert (SME) for GMP and Data Integrity (DI) requirements. Must effectively work as a team with internal customers, peers, and management through effective oral and written communication. Must evaluate the compliance of records, documents, and Quality Systems to ensure that the site is operating per GMP and Data Integrity requirements.

Essential Functions

1. Collaborate and provide expert reviews to ensure records, documents, and Quality Systems meet GMP and DI requirements (promote quality, DI, and GMP awareness).
2. Support external and internal audits for the Client Americas sites.
3. Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for Client Americas sites.
4. Develop and manage processes that ensure the Exton site remains in compliance with global quality policies, regulatory requirements, and industry requirements, including periodic review and consolidation.
5. Other duties as assigned to facilitate ongoing Quality activities as required, including collaboration with other Quality groups.

Requirements

Education and Experience

1. Bachelor’s degree (preferably in a science-related discipline) preferred.
2. 5 – 7 years of experience working with Quality Systems (Deviation, Change Control, CAPA, audit, etc.).
3. Demonstrated proficiency and experience in working with Quality Systems IT applications.
4. Training within a regulated Pharmaceutical/biotech/medical device environment.
5. Understanding and application of CGMP’s (EU, JP, US).
6. Detailed knowledge and application with electronic Quality Systems (i.e. TrackWise, Documentum).

Technical

1. Strong attention to detail as demonstrated through consistent quality of work.
2. Excellent written and verbal communication skills.
3. Computer proficiency in MS Word and Excel, Project and Visio required.
4. Demonstrates process orientation—thinks through required steps and sequencing to ensure quality work output.
5. Strong project management skills are preferred.
6. Ability to anticipate potential problems and take proactive action to avoid/minimize impact.
7. Anticipates consequences of actions and how they impact other areas.
8. Ability to independently prioritize, plan and schedule workflow.
9. Timely follow up to ensure satisfactory resolution to issues.
10. Knowledge of CGMPs (relevant laws, guidance, directives and industry practice), and demonstrated ability to apply learnings appropriately.
11. Ability to interpret and apply GMPs, relevant laws, guidance’s and directives to extremely complex pharmaceutical situations.
12. Ability to work and coordinate activities across multiple functional groups with a sense of professionalism and urgency.
13. Ability to work collaboratively with internal and external team members and customers/contacts.
14. Self-motivated; able to work with minimal supervision. Exercises independent judgment in evaluating compliance.
15. Ability to work in a controlled environment.
16. Good attendance and reliability.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing