Almac Group is currently seeking a Associate Director – Quality Assurance for our Audubon, PA location. The Associate Director – Quality Assurance is responsible for execution, maintenance, and continuous improvement of the Almac Pharma Services quality system at the Audubon site including managing the processes for batch document review, product disposition, change control, deviation investigations/CAPA, complaints, and controlled document lifecycle management.
The Associate Director – Quality Assurance assures that no product is released until its quality/ compliance has been deemed satisfactory and it is confirmed to have been packaged and held in accordance with Almac Pharma Services standard operating procedures, current good manufacturing practices, and client expectations.
Responsibilities include but are not limited to: - Manage the performance of various quality system elements to ensure compliance, add value, and ensure that quality is a strategic advantage for the Company. Ensures Almac Pharma Services’ adherence to cGMPs, SOPs, and customer instructions through performance of job functions.
- Oversees the activities of the QA Staff through the Quality Assurance Team Leads responsible for Product Quality and Quality Management Systems (QMS) including:
- The change control system to ensure that all potential patient/product impacting changes are appropriately planned, risk assessed and actioned in the defined timeframes and in a prospective manner.
- The deviation management system to ensure that all deviations and lab investigations are appropriately reported, investigated, and CAPA actions identified in the agreed timeframes.
- The Product Complaint system to ensure that complaints are received, assessed, investigated and formally responded to in line with procedural timelines.
- The vendor query system to ensure that queries are components and incoming materials are identified, reported, investigated and managed in conjunction with approved suppliers to minimize the risk on product quality.
- Manage the quality aspects of New Product Introduction and Commercial Product packaging and assure that all client, and regulatory requirements are met.
- Provide quality review and approval of GMP records including but not limited to: Executed Batch Records, SOPs, Policies, Guidelines, Specifications, Quality Control Methods, Validation Protocols and Reports, Analytical Data Packs, and Master Batch Records
- Manage the Batch Record Review process in accordance with the business KPI’s and assure appropriate disposition decisions are made according to product quality and compliance requirements.
- Manage the Document Control Systems, including control of SOPs, Master Document templates, Production Records, supporting documentation and the lifecycle phases of all site Controlled Documents
- Be an SME on the Almac Pharma Services Quality System and a primary contact for other departments providing quality advice and guidance to ensure compliance.
- Periodically review quality systems and practices for improved efficiency and to ensure greater compliance.
- Develop and manage the collection of site and client Quality metrics (quality indicators / KPIs) to assess the level of compliance and target areas for improvement.
- Manage the QA staff and appropriately schedule resources to complete GxP related activities to meet business needs.
- Interact with Quality Assurance, Client Services, Operations, Logistics, and Client personnel to ensure prompt and effective response to quality issues and technical queries.
- Be responsible for the development of staff within the QA department including mentoring direct reports and ensuring that the training and development of the QA team members is appropriate to their position.
Qualifications:
Required Experience / Education:
- Bachelors Degree
- 10 years GMP related experience in the Quality/Compliance field and min 3 years in a Supervisory or Management Role
- Full understanding of cGMPs
- Pharmaceutical Quality Systems
- Packaging/Labeling/Inspection
Preferred Experience / Education:
- Bachelor of Science Degree in a scientific/technical field of study (Chemistry, Biology, Microbiology, Engineering, etc)
- Six Sigma
- Root Cause Analysis
- Statistical Process Control
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
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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 over 7,500 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.
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Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.