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Product Quality Lead - Biologics and Gene therapy (home-based)

Employer
Hobson Prior
Location
Homeworking
Salary
£63.25 - £108.43 per hour
Start date
18 Jan 2021
Closing date
15 Feb 2021

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Contract
Experience Level
Management

Job Details

A new opportunity has arisen for a Product Quality Lead - Biologics and Gene therapy to join a specialty biopharmaceutical company in Dublin on a 6-month contract basis. The main purpose of this position is to provide global quality oversight of the organisation's products, across the assigned product technology platform, from late clinical development phase through commercialization and throughout lifecycle.

Job Responsibilities:

  • Empowered quality representative for Global Product Teams, translating the global commercial strategy into operational strategy, for execution by the relevant Business Units.
  • Responsible for consulting and informing all relevant quality stakeholders to ensure aligned, strategic decision making.
  • To provide quality expertise in accordance with global regulatory requirements and internal policies in the creation of Product Characterization, Product Specifications, Method Validation, Stability and Comparability assessments for tech transfers.
  • Lead product quality related cross-functional teams.
  • Support quality review of regulatory submissions (i.e. filings, annual reports, responses to questions, progress reports for regulatory commitments), ensuring submissions are in line with the operational strategy, GMP requirements and are verified for accuracy and data integrity.
  • Represent Product Quality program in CMC meetings with global regulatory agencies and during regulatory inspections
  • To represent Quality in Global CMC and Commercialization teams
  • Quality lead supporting business growth in product launch, due diligence, divestment and integration activities and works in partnership with relevant stakeholders to influence quality, supply and regulatory strategy.
  • Maintain oversight of product performance and develop countermeasures via strategic and tactical quality input to develop sustainable compliant product with continuity of supply.
  • Supports the Incident Escalation process.
  • Support the definition of product critical quality attributes, deliver and drive control strategy, deliver phase-appropriate product specifications.
  • Any other assigned duties.

Key Skills:

  • Ability to work autonomously, and an understanding of when to consult/inform/escalate.
  • Strong relationship building skills, and ability to work in partnership cross functionally with global stakeholders.
  • Business alignment acumen with ability to understand commercial strategy and financial literacy.

Requirements:

  • BSc. / BEng. or equivalent essential, MSc. /Eng. preferred, business related post graduate education an advantage.
  • At least 5 years' experience across a range of quality, technical operations or regulatory functions, experience operating at global level essential.
  • Operational experience as a licensed QP is admirable.
  • Subject Matter Expertise in one product platform (Biologics, Plasma or Small Molecule).

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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