Quality Control Technical Lead

ALMAC Group; Souderton (Montgomery County); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, Vision & Dental benefits from

20 days PTO per year

12 holidays

Disability & Life Insurance

401k company contribution

Professional development programs

Job summary

Almac Group in Souderton, PA is seeking a Quality Control Technical Lead to act as the Quality SME on local and global projects, guiding changes in processes and risk assessments within the Quality department. You will work with sponsors and stakeholders, lead change control, generate validation documentation, and ensure timely deliverables while maintaining cGMP compliance.

This senior role partners with global Quality Management and SOP teams, offering growth opportunities in drug development

Qualifications

• HS Diploma or Equivalent required.
• 5+ years pharmaceutical experience with HS Diploma or equivalent.
• 3+ years pharmaceutical experience with Associates Degree.
• 1+ years pharmaceutical experience with bachelor's degree.
• Knowledge of Current Good Manufacturing Practices (cGMP).
• Working with Quality Systems.

Responsibilities

• Act as the Quality SME on local or global projects and provide Quality input to requirements and validation documents.
• Lead implementation of new processes or significant changes within the Quality department and manage risk assessments.
• Capture decisions and report project status to Quality Management.
• Identify impacts and compliance risks and highlight to the project team.
• Ensure deliverables are completed in a timely manner.
• Create/update SOPs and educational materials in collaboration with department SMEs.

Skills

Quality SME

cGMP knowledge

Quality Systems

Education

HS Diploma or Equivalent

Associates Degree

Bachelor's degree

Job description

Almac Group is currently seeking Quality Control Technical Lead for our Souderton, PA location. The role of the Quality Control Technical Lead is to act as the nominated Quality SME, providing support on specific local or global projects that require Quality input and expertise so that they are appropriately supported. In addition, the role will facilitate the implementation of new processes (or significant changes) within the Quality department and risk assessment activities specific to their area.

Responsibilities include but are not limited to:

• Act as the Quality SME on local or global projects to which you are assigned.
  • Work closely with the sponsor, key stakeholders, and project team
  • Provide Quality input into the user requirements gathering and support the generation and approval of any associated change control, risk assessment and validation documentation
  • Capture key decisions and provide regular updates to global Quality Management, highlighting any areas of concern and gain consensus on any discussion points requiring resolution
  • Identify impacts and compliance risks and highlight to the project team
  • Ensure deliverables to which you are assigned are completed in a timely manner
  • Communicate updates to the wider Quality teams as required
• Facilitate the implementation of new processes or significant changes within the Quality department. In doing so:
  • Work closely with Quality management (locally or globally) to define the scope of the initiative or change
  • Lead the implementation exercise, track tasks, and monitor progress, providing clear visibility of key milestones and deliverables
  • Facilitate the user requirements gathering and support the generation of process / data maps and the compilation and approval of any associated change control, risk assessment and validation documentation
  • Work closely with department SMEs to generate / update SOPs
  • Work closely with department OJT to develop educational material relevant to the changes being introduced
  • Provide regular updates to local or global Quality Management, highlighting any areas of concern, gain consensus on any discussion points requiring resolution and report on project status
  • Identify impacts and compliance risks and highlight to the project team
  • Highlight potential inter-dependencies and identify business readiness activities
  • Facilitate effectiveness checks

  Qualifications:

  Required Experience / Education:

  • HS Diploma or Equivalent
  • 5+ years pharmaceutical experience with HS Diploma or equivalent
  • 3+ years pharmaceutical experience with Associates Degree
  • 1+ years pharmaceutical experience with bachelor's degree
  • Knowledge of Current Good Manufacturing Practices (cGMP)
  • Working with Quality Systems

  Preferred Experience / Education:

  • Bachelor's degree with science background
  • Previous experience working under an established Quality System or within a Pharmaceutical /GxP environment
  • Knowledgeable in GxP regulatory requirements
  • Knowledge of Packaging/Labeling/Storing/Shipping Clinical Supplies
  • Familiar with Clinical Trial Process

  What can Almac Group offer you?

  • Medical, Vision & Dental benefits from the 1st of the month following start date
  • 20 days PTO per year, accrued monthly following start date
  • 12 holidays per year
  • Company paid Long and Short-term disability along with Life Insurance
  • 401k company contribution
  • Professional development programs/ continuous learning opportunities

  Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing 6,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. 'Partnering to Advance Human Health' is more than just a tagline - it is our way of life.

  Embracing diversity is at the heart of enhancing Almac Group's unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.

  Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.

  EEO is the Law

  EEO is the Law GINA Supplement

  Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [e-mail] to request assistance.