Job Overview:
We are seeking a highly experienced Biotech QA Manager to join our client's team.
Key Responsibilities:
* Negotiate and approve quality agreements
* Lead preparation of sites for regulatory inspections and audits
* Presentation on topics during inspection, demonstrating appropriate behaviors and knowledge
* Review and approval of master batch records
* Quality approver for deviations, change controls, CAPA
* Prepare inspection playbooks
* Identify and mitigate risk at CMO or testing laboratories
* Perform Person in Plant activities as required
* APR data provider
* Manage audit commitments to completion
* Perform tactical batch disposition activities in support of lot release
* Decision to release or reject batches
* Decision to approve or reject deviations, change control, CAPA
* Decision to approve QAGR
* Provide quality position on GMP-related topics and strategy for the site
* Decision to approve master batch records/raw material specifications
Requirements:
* Doctorate degree with 2 years of directly related experience or equivalent combination
* Able to facilitate and influence senior stakeholders and partners
* Strong project management, problem-solving, and analytical skills
* Demonstrated ability to lead cross-functional teams and consistently deliver on-time, high-quality results
* Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
* Experience driving decision making by using DAI principles
* Experience with variation management process
* Autonomous individual who can hit the ground running
* Good oversight of deviation management, reg affairs, filings, regulatory guidance, e.g., HPRA requirements
Package:
* Contract role: Hourly rate €60 - €70 per hour
* Minimum 12-month contract
* Onsite expectations: Fully remote