Almac Group is currently seeking a Director of Quality Assurance for our Audubon, PA location. The Director of Quality Assurance will be responsible for the operations and management of the Quality Assurance (QA) department and the maintenance and development of the quality system/s for Almac Pharma Services LLC to effectively meet the needs of the business and to ensure compliance with regulatory guidelines.
Responsibilities include but are not limited to:
- Ensure that the QA department at the Audubon site has the necessary resources and skill sets to support the needs of the Pharma Services business.
- Responsible for oversight of site activities, assuring that products are manufactured in compliance with cGMP, FDA, EU guidelines and CFR 820.
- Ultimately responsible for the operations of the Quality Assurance group to ensure compliance with approved work schedules, such as the periodic review, re-qualification and annual product review schedule, review of executed batch records, and any associated investigations and changes to ensure compliance with GMP and regulatory requirements.
- Develop and maintain the Quality Management System on site, in compliance with current Regulatory guidelines
- Oversee the development and maintenance of quality systems for the review and approval of key quality system documentation, such as change requests, deviation reports, CAPA plans, lab investigations and complaint investigations.
- Responsible for QA oversight of the operations of the Quality Control laboratory, ensuring that QC operations are conducted in compliance with the Quality Management System, regulatory requirements and the needs of the Almac Pharma Services business.
- Acts as Representative of the Quality Unit of Almac Pharma Services LLC:
- to any Regulatory Authorities
- for customer and external audits
- at Quality Management team meetings to determine the Pharma Services approach to compliance with regulatory guidelines and to agree any elements, which require escalation to the Senior Management team.
- Make representations whenever quality standards appear to be falling short of Good Manufacturing Practice(s) and communicate general quality issues within Pharma Services, as appropriate, to the VP of Quality Assurance, the Senior Management Team and the site VP of Operations for the Audubon site.
- Provide input into the Training and Development program for Almac Pharma Services staff from a Quality and/or GMP perspective
- Ensure training has been received before undertaking specific duties and that all training is document in training records.
- Maintain knowledge and experience up to date in light of technical and scientific progress and changes in quality management relevant to the products processed on site.
- Mentor and coach direct reports and make recommendations for individual staff development within the company.
- Manage Technical/Quality Agreements with contract givers and third-party service providers, relevant to the Audubon site.
Qualifications:
Required Experience / Education:
- Bachelor degree required; concentration in biological, chemical or health sciences preferred
- 10+ years of experience in Quality and personnel management
- Knowledge of the GMP requirements of the pharmaceutical industry
Preferred Experience / Education:
- Bachelors Degree in related field
- Pharmaceutical industry experience in a Quality role in commercial manufacturing or packaging operations
- Experience in FDA 21 CFRs Part 210 and 211, cGMPs required.
- Experience in managing and hosting regulatory inspections.
- EU GMP knowledge
- Knowledge of Quality Control systems and procedures
- Experience within a Pharmaceutical Contract Manufacturing Organization.
- Experience of the validation requirements of the Pharmaceutical Industry.
What can Almac Group offer you?
- 20 days PTO per year, accrued monthly following start date
- Medical, Vision & Dental benefits from the 1st of the month 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 7,000 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.
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [email protected] to request assistance.
