QA Systems & Compliance Technical Manager

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded
in 1996, headquartered in Pomona, California, USA, with Global operations in
Ireland, India, Singapore, Australia and the US, serving 350 clients in more
than 23 countries worldwide. We provide cloud -based software solutions for
Quality Management and Regulatory Inspections, pharmaceuticals contract
manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model
by aligning our EVP as one of the unique selling point which includes the
opportunity to work with the most talented cohort of like -minded professionals
operating in the Pharma/ Biotech Industry. We offer a permanent contract of
employment giving exposure of working in Top Pharmaceutical client sites in a
diverse -cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide
unparalleled empowering career development though Learning & Development
in -house training mentorship through constant guidance to facilitate career
progression. We believe in creating high performing teams that can exceed our
client’s expectations with regards to quality of all scalable and business unit
deliverables, staying under budget and ensuring timelines for our deliverables
are being met.

Requirements

Essential Job Functions:

• Act as a business process manager for applicable quality
  systems.
  
• Assess GMP and regulatory compliance risk areas and
  develop and implement risk mitigation measures in conjunction with the
  accountable parties.
  
• Work with key stakeholders to identify and implement
  system improvements,
  
• Analyse performance through metrics and trending,
  
• Troubleshoot issues and support the business with
  queries,
  
• Benchmark leading practices & identify opportunities
  to enhance systems,
  
• Liaise with global colleagues to share learnings to
  ensure consistency across the network and alignment with global processes.
  
• Provide QA review and/or approval for Supplier Management
  and other Quality System activities impacting GxP operations, including (but
  not limited to):
  
• Deviations
  
• Changes
  
• Specifications
  
• Technical / Quality Agreements
  
• Provide additional support to Quality Systems and
  Compliance team:
  
• Support audit and inspection activities for site,
  including preparation, participation, and follow up actions.
  
• Lead activities associated with the site quality
  management review process.
  
• Other duties as assigned.
  

Qualifications & Experience:

Education:

• Bachelor’s degree in Pharmaceutical Sciences, Process
  Engineering or related discipline.
  

Experience:

• 10–15+ years experience within GMP -regulated
  pharmaceutical or biotechnology environments
  
• 3 -5 years in leadership roles, with experience in people
  management and a proven ability to influence cross -functional teams and
  stakeholders.
  
• Significant hands -on experience supporting regulatory
  inspections.
  
• Knowledge of EU GDP Guidelines and regional regulatory
  requirements.
  
• Proven ability to lead change initiatives and drive
  improvements within and across functions which enable compliance and mitigate
  risk
  
• VIVA Vault - QMS
  

Skills:

• Excellent communication and influencing skills across all
  organizational levels.
  
• Planning and organising skills.
  
• Detail -oriented, analytical thinker.