Biotech QA Manager - External Suppliers - Remote

Biotech QA Manager - External Suppliers - Remote

Office / Project Location : Dun Laoghaire, Dublin

Employment Type :  Contract

Work Location :    Remote

Pay : €60 - €70 per hour

Experience :  10+ years

Visa : EU passport or Stamp 4 visa required

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.

This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.

Quality and Compliance Oversight of a contract lab, CMO or a raw material SRE. Alignment with CTA / Marketing Application.

Be an integral quality member of cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc.

Negotiator and Approver of quality agreements

Lead the preparation of the site for and Represent Amgen at product-specific Regulatory Inspections and / or during Notified Body audits of CM Site, as applicable or required.

Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas

Review / Approve Master Batch Records

Quality approver for deviations, change controls, CAPA

Prepare inspection playbooks

Identify and mitigate Risk at the CMO or testing Laboratories and / or escalate to management

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 (Dynamic is different for SREs)

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 & 2 years of directly related experience OR

Master’s degree & 4 years of directly related experience OR

Bachelor’s degree & 6 years of directly related experience OR

10 + years biotech or pharmaceutical industry experience

Additional European Languages - desirable not essential

Significant Quality experience at Aseptic Manufacturing facilities

Able to facilitate and influence senior stakeholders and partners

Able to successfully manage workload and timelines

Familiarity with basic project management tools

Ability to negotiate a strategic position after taking feedback from multiple sources

Strong project management, problem-solving, and analytical skills

Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results

Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution

Ability to operate in a matrixed or team environment with site, functional, and executive leadership

Experience driving decision making by using DAI principles

Experience with the “variation management” process

Somebody who can be autonomous and doesn’t need a huge amount of day-to-day hand holding

They really need to hit the ground running as much as they can

Willing to get involved

We would be looking for candidates with a very strong quality mindset because they may not be the person that has all the answers, but they will be the one who has taken the information from the CMOs and work at who do you need to involve them from a company perspective?

So would need a good oversight of deviation management, reg affairs, filings, regulatory, the guidance, e.g., HPRA requirements, so a very broad experience in quality.

Somebody who has worked in an external manufacturing environment.

Package

Contract role - Hourly rate €60 - €70 per hour

Minimum 12 month contract

Onsite expectations : Fully remote.

There could be requirements to go on to site in Dun Laoghaire as that’s the location the team are aligned to, but onsite expectations are not on a regular frequency.

We anticipate that we would need the individual to come onsite at least once a quarter, and there could be the occasional ad-hoc requirement to go onsite.

Travel : We do not foresee a huge amount of travel but feel it’s worthwhile flagging and the travel extends to Europe.