Operations Compliance Value Stream Lead

Summary about this job

Detail information about job Operations Compliance Value Stream Lead. Terms and conditions vacancy

• Great leadership opportunity- immediate start.
• Opportunity to lead and influence a driven team.
• Work in a culture which drives world class performance to put our patients first.

If you are looking for a job that can find you a purpose in life and lead others to achieve …than look no more as at Pfizer Melbourne we have it all? If you have answered Yes to the above, than keep reading and learn more about Pfizer and our aspiring high performing, Operations team.

Pfizer is the world's leading provider of injectable drugs and infusion technologies. Through our broad, integrated portfolio, we continue to improve patient and caregiver safety while reducing healthcare costs. Our Mulgrave manufacturing facility is the flagship site for the supply of critical care of Oncology and High Potency sterile pharmaceuticals. As a proud Australian manufacturer we continuously improve our quality, safety and technical capabilities to ensure we deliver affordable healthcare, reliable supply and effective products for critical care medicines around the world.

A role at Pfizer Melbourne is unlike any other. Offering talented individuals the opportunity to own a career with real impact, our people go to work each day in the knowledge that every development signifies real, positive progress.  Our Operations Team is made up of resilient leaders aiming to drive step change in a highly complex and innovative manufacturing environment to deliver high value product to our patients across the globe.  

If you are a looking for a purpose at work, and are passionate, accountable and work collaboratively then we want you in our team, as we aim to improve the health of people across the globe.

The Operations Compliance Value Stream Lead responsibilities include:

• Manage and direct the functions and staff of the Compliance group:
  • Regulatory Compliance: Internal Audits, Vendor Audits, Annual Product Quality Reviews, Complaints Review and Trending, Batch Data Trending, Field Alert Reporting, Compliance Issues Escalation Management (Notification to Management)
  • Systems Compliance: Change Control, Documentation
  • Training Compliance within Production
• Drive a proactive quality culture across the value stream to deliver products Right First Time.
• Manage quality systems relating to Compliance activities in accordance to procedures to meet business needs and agreed targets in Production.
• Support external (regulatory, customer and corporate) and internal audits to ensure the business remains in compliance and commitments are closed by agreed due dates.
• Monitor compliance systems within Production to ensure their effectiveness.
• Provide direction and guidance on GMP Compliance matters within Production facility.
• Prepare and/or approve regular reports on department performance and quality metrics.

• Manage robust development/training plans for direct and indirect reports to build capability and pipeline of talent in production. 
• Mentoring/coaching of colleagues within the Value Stream.
• Foster an environment of continuous improvement to enable site to transform to World Class standards.   

To be considered for this opportunity you will have:

A minimum Bachelor’s Degree in an Engineering, Scientific or related discipline is required for this role.

Years of Experience: >10 years’, with at least 5 years in a Quality function and Manufacturing Environments. Minimum of 8 years in Management positions.

The Operations Compliance Value Stream Lead must also at minimum demonstrate the following knowledge/skills:

• Demonstrated knowledge of cGMP and Regulatory requirements for Australia, EMEA and USA.
• Demonstrated experience in internal and external auditing processes
• Demonstrated work prioritization skills
• Demonstrated experience in meeting project/work timelines and achieving required outcomes
• Demonstrated ability to keep comprehensive and accurate records in a multi-faceted environment
• Well-developed written and verbal communication skills
• Well-developed consultation and negotiation skills
• Well-developed computer Literacy
• Leading team through change management.
• Strong Leadership attributes and ability to manage conflicting priorities.
• Sound knowledge of Aseptic filling.

By joining Pfizer you will partner with colleagues of diverse backgrounds and abilities, people who contribute to all aspects of what we do—from drug development to marketing, technology to sales, and so much more.  Interested or know someone who is? Then APPLY NOW. All applications will be considered based upon merit.

On application you will be redirected to register your details. Once you have completed the registration process, please search and apply for this opportunity via Job ID: 4703967.

Disclaimer: Pfizer does not accept unsolicited agency resumes. Pfizer is not responsible for any fees related to unsolicited resumes.