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AX-7199 CMO Quality Assurance Manager

AXESS Ltd Published: 27th June 2019
Location
Berkshire, United Kingdom
Job Type

Description

Ref: AX-7199

 

JOB SUMMARY

AXESS are partnering with a global biopharma to seek an ambitious QA Manager to provide GMP quality and strategic oversight to global partners working across various products including biologics and small molecules.

 

BACKGROUND

Global specialty-driven biotechnology group

Offer products in oncology and endocrinology amongst others

Strong pipeline

Launches anticipated over the next 2 years

Excellent potential for career development within the QA group including succession planning into QA Director role in the mid-term

Flat structure with every role in the QA group offering high exposure to company senior leadership team

Travel 15% to 20%

 

PRIMARY DUTIES

Quality Assurance

Deploy  and  maintain  GxP  Quality  Management  Systems  with  CMOs  and  Testing Laboratories to ensure compliance with regulations and inspection readiness at all times.

Deploy and maintain a Quality Auditing capability with use of CAPAs to identify and track required improvements.

Review  and  sign-off of  master  production,  process  validation  and  cleaning  validation documentations provided by CMOs.

Quality Strategy

With the Director of Quality and Director of Relationship Management, develop a quality strategy aligned with the overall business strategy

Reduce and mitigate product risks as well as developing opportunities for improvement

Risk Management

Identify, remediate and mitigate risks associated with company  products and systems

Continuous Improvement

Identify and implement opportunities to simplify business processes including sampling, testing and data generation.

Support initiatives to meet or exceed Quality objectives. Contribute to continuous improvement planning and execution.

Contribute to the deployment of the Global Technical & Quality roadmap for 3rd party manufacturing.

 

QUALIFICATIONS / EXPERIENCE REQUIRED:

Degree in a Life Sciences discipline, ideally in Pharmacy, Chemistry, Microbiology or Engineering

Significant hands-on experience gained in both Quality Assurance and Quality Control departments

Thorough knowledge of cGMP guidelines gained through practical experience of supporting cGMP manufacturing operations.

Extensive experience of Internal & External Quality auditing, CAPA management, deviation management & risk assessments. Preparation for FDA and EMA inspections.

Knowledge of biotech and aseptic manufacturing and processes, and product testing methods.

Familiarity with LIMS, EQMS (Trackwise), EDMS (Documentum) and EBR (Syncade) or equivalent Quality systems.

 

BENEFITS:

Corporate

 

TO APPLY:

For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300 quoting reference 7199.

To apply, please click the APPLY ONLINE button.

 

KEYWORDS:

QA Manager, Quality Assurance, CMO, CMOs, contract manufacturing organsiation, Quality Assurance  Manager, Manager QA GMP, risk evaluation, risk management, CAPA, audit, GxP, QMS, Quality management, responsible person status, GxP Compliance, quality assurance, manager Quality assurance, Global Quality Assurance,  manager Global Quality Assurance,   quality assurance, QA,GMP, global QA, global quality assurance, Manufacturing, senior manager global QA, audits, critical deviations, change control, risk assessment,  root cause analysis, QA Supply chain, QA logistics, quality compliance,  global quality, global QA, external manufacturing, 3rd party manufacturing

 

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market.

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