Seuss Consulting

Associate Director R&D QA (GLPGCP)

Location
Netherlands
Salary
Competitive
Posted
11 Feb 2021
Closes
13 Mar 2021
Ref
137918
Discipline
R & D
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Associate Director R&D QA (GLP/GCP)

We are searching for an experienced, collaborative, and patient-centric Associate Director R&D QA (GLP/GCP). Are you ready to take the next step in your career?

The right candidate will form a vital, key role within Quality Assurance support of pre- and non-clinical development.
If you enjoy designing, implementing, and managing risk-based Quality Systems to support in-house development laboratories supporting GLP and GCP studies, this is the role for you.
We are looking for a highly collaborative individual who can provide quality and compliance leadership to internal teams, consultants, and external vendors.

Work for an organization that recognizes your scientific expertise.
Our well-respected client is dedicated to transforming patient lives through innovative and ground-breaking therapies. Are you ready to become a part of their story?
The ideal candidate has experience with small to medium-sized biotech and has proven proficiency and affinity to building Quality Systems.
You are a dynamic individual who can collaborate with cross-functional teams and use your flexible and solution-orientated approach to identify, prioritize, and remediate compliance gaps and risks.

Showcase Your Innovative Skills and make an impact.
Do you enjoy:
  • - Working in a collaborative, dynamic, and innovative environment.
  • - Developing cross-functional relationships.
  • - Prioritizing tasks and working with a sense of urgency.
Do you have:
  • - Proven understanding of early drug development.
  • - Experience with compliance auditing.
  • - Solid laboratory experience.
  • - A passion for bringing innovative therapies to patients with serious unmet medical needs.
  • - Experience with leading execution of risk-based quality and compliance strategies.
  • - Effective communication and interpersonal skills, including the ability to interact with all levels within the organization.
  • - Integrity and commitment to high ethical and compliance standards.
  • - A sense of humour.
Qualifications:
  • S. Degree in biology, chemistry, or an allied health field with at least 8 years in the pharmaceutical or biopharmaceutical industry.
  • S Degree in biology, chemistry, or an allied health field with at least 6 years in the pharmaceutical or biopharmaceutical industry.
  • Expertise in the application of global GLP standards is mandatory. Expertise in global GCP standards is desirable.

Role Responsibilities:

  • Provide R&D Quality Assurance support to bioanalytical assay development, execution, and transfer.
  • Provide QA oversight of internal and contract laboratories supporting GLP and GCP studies.
  • Collaborate with cross-functional teams to identify, prioritize, and remediate compliance gaps and risks.
  • Develop and implement risk-based audit and oversight strategies for GLP and GCP laboratory vendors and internal processes.
  • Manage routine audit conduct by external consultants.
  • Lead high-complexity and high-risk audits where representation is required.
  • Lead cross-functional investigations, root cause analysis, and CAPA development for significant departures from GLP at vendors.
  • Collaborate with supported functions to develop and implement inspection readiness plans.
  • Lead quality and compliance awareness throughout the company organization by example and by coordinating cross-functional training opportunities.
  • Approximately 20% domestic and international travel is required.

More about the role and client
This is an exciting opportunity to work for a well-respected organization. Our client offers a collaborative and friendly environment and a real investment into employee education, growth, and development.
The role is open to candidates with the right to work in the EU. Unfortunately, they are not able to offer visa sponsorship for this role.

Covid-19
Employees are currently working from home, with restricted numbers in the laboratories.

Our recruitment process.
We go beyond traditional recruitment; we work closely with you to ensure an unrivalled, personal candidate interview experience throughout our entire process.
Our long-standing relationship with this particular client allows us to fully support you through the recruitment process, providing you with all the role insight and knowledge you need for this 2-part interview process.
Our commitment goes beyond placement, and you can expect us to be fully engaged well after your placement.
Our recruitment process is entirely confidential. Your details will never be shared without your prior consent.

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