Quality Control Technical Lead

Position: Quality Control Technical Lead Location: Souderton, PAJob Id: 5770 # of Openings: 1 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 teamProvide Quality input into the user requirements gathering and support the generation and approval of any associated change control, risk assessment and validation documentationCapture key decisions and provide regular updates to global Quality Management, highlighting any areas of concern and gain consensus on any discussion points requiring resolutionIdentify impacts and compliance risks and highlight to the project teamEnsure deliverables to which you are assigned are completed in a timely mannerCommunicate updates to the wider Quality teams as requiredFacilitate 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 changeLead the implementation exercise, track tasks, and monitor progress, providing clear visibility of key milestones and deliverablesFacilitate 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 documentationWork closely with department SMEs to generate / update SOPsWork closely with department OJT to develop educational material relevant to the changes being introducedProvide 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 statusIdentify impacts and compliance risks and highlight to the project teamHighlight potential inter-dependencies and identify business readiness activitiesFacilitate effectiveness checksQualifications:Required Experience / Education:HS Diploma or Equivalent5+ years pharmaceutical experience with HS Diploma or equivalent3+ years pharmaceutical experience with Associates Degree1+ years pharmaceutical experience with bachelor’s degreeKnowledge of Current Good Manufacturing Practices (cGMP)Working with Quality SystemsPreferred Experience / Education:Bachelor’s degree with science backgroundPrevious experience working under an established Quality System or within a Pharmaceutical /GxP environmentKnowledgeable in GxP regulatory requirementsKnowledge of Packaging/Labeling/Storing/Shipping Clinical SuppliesFamiliar with Clinical Trial ProcessWhat can Almac Group offer you?Medical, Vision & Dental benefits from the 1st of the month following start date20 days PTO per year, accrued monthly following start date12 holidays per yearCompany paid Long and Short-term disability along with Life Insurance401k company contributionProfessional development programs/ continuous learning opportunitiesWant to see our latest job opportunities? Follow us on LinkedInAlmac 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.RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.EEO is the LawEEO is the Law GINA SupplementAlmac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at View email address on click.appcast.io to request assistance. Apply for this Position