What are the responsibilities and job description for the QA Manager - Support position at Almac Group?
Almac Group is currently seeking a QA Manager-Support for our Durham, NC location. The QA Manager-Support will manage all Quality Assurance functions responsible for reviewing documentation and ensuring compliance with the principles of GMP, customer-approved procedures, and Almac SOPs. The QA Support Manager will have responsibility for the QA Key Account Manager, QA Lead Investigator, QA -OJT and the QA Temperature Services functions. Functions may cover all Almac sites.
M-F 8-5
Responsibilities include but are not limited to:
Manages the activities of QA staff directly and through the QA Supervisor-Temp Services.
Oversees PQS functions which includes the compilation, review and approval of SOPs, Quality Incident reports, Technical Query reports, risk assessments and change request documents. In such circumstances this approval may be in a global capacity, where consideration will have been given to impacts affecting other Clinical Services sites.
Oversee provision of Quality Temperature Services with Global Quality support offered Almac across all sites. This includes review and approval of global temperature services instructions, review and approval of monitor profiles and association to protocols, review of in-transit and at-site temperature excursions as well as lifecycle monitoring of CTM.
Oversees QA Key Account Managers which establish and maintain the direct Quality to Quality relationships with Key Customers to ensure their needs and expectations are appropriately managed and these relationships are developed and maintained. Provide Quality guidance during the review, design, risk assessment, and optimizations of new or existing business processes relating to Key Customers to promote continuous improvement.
Ensure all Quality managers are assisted with the on-boarding of new hires ensuring, all appropriate facility and system access has been granted, and training in core SOPs has been successfully delivered and approved. Facilitate on-the-job training to new and existing employees in Quality related activities pertinent to their roles. Oversee the creation of educational materials where appropriate. Hires, trains, and develops Quality Assurance personnel. Acts as key trainer in cGMP and SOP training of Almac personnel.
Interacts with Quality, Business Development, Project Services, Operations, Logistics, and customer personnel to ensure prompt and effective response to quality issues and technical queries. Serves as a primary point of contact for client and internal customer representatives in regard to receiving, processing, and relaying quality information.
Develops and implements document control systems including the control and routing of documents such as SOPs, master document templates, quality incident reports, risk assessments, technical queries, change requests, and validation documentation. This includes the use of electronic systems applicable to all Almac sites.
Provides oversight for customer-requested audits of Almac, communicating audit results to management and ensuring prompt and appropriate response to deficiencies and technical queries.
Deputizes for the Director of Quality, as necessary.
Qualifications:
Required Experience / Education:
Bachelors Degree in Science
3-Year Leadership Role
2-Year with Direct Reports
3-Year Quality Systems
3-Year Change Control
Packaging or Manufacturing Current Good Manufacturing Practices (cGMP)
Preferred Experience / Education:
A degree in biology, pharmaceutical, or chemical sciences is preferred
5 Year Quality Assurance/Control
5-Year Packaging/Manufacturing
5-Year Validations
1-Year Supervision
Packaging of Clinical Supplies
Global Regulatory Requirements
Training
Quality Auditing
What can Almac Group offer you?
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.
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 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 ADARequest@almacgroup.com to request assistance.
M-F 8-5
Responsibilities include but are not limited to:
Manages the activities of QA staff directly and through the QA Supervisor-Temp Services.
Oversees PQS functions which includes the compilation, review and approval of SOPs, Quality Incident reports, Technical Query reports, risk assessments and change request documents. In such circumstances this approval may be in a global capacity, where consideration will have been given to impacts affecting other Clinical Services sites.
Oversee provision of Quality Temperature Services with Global Quality support offered Almac across all sites. This includes review and approval of global temperature services instructions, review and approval of monitor profiles and association to protocols, review of in-transit and at-site temperature excursions as well as lifecycle monitoring of CTM.
Oversees QA Key Account Managers which establish and maintain the direct Quality to Quality relationships with Key Customers to ensure their needs and expectations are appropriately managed and these relationships are developed and maintained. Provide Quality guidance during the review, design, risk assessment, and optimizations of new or existing business processes relating to Key Customers to promote continuous improvement.
Ensure all Quality managers are assisted with the on-boarding of new hires ensuring, all appropriate facility and system access has been granted, and training in core SOPs has been successfully delivered and approved. Facilitate on-the-job training to new and existing employees in Quality related activities pertinent to their roles. Oversee the creation of educational materials where appropriate. Hires, trains, and develops Quality Assurance personnel. Acts as key trainer in cGMP and SOP training of Almac personnel.
Interacts with Quality, Business Development, Project Services, Operations, Logistics, and customer personnel to ensure prompt and effective response to quality issues and technical queries. Serves as a primary point of contact for client and internal customer representatives in regard to receiving, processing, and relaying quality information.
Develops and implements document control systems including the control and routing of documents such as SOPs, master document templates, quality incident reports, risk assessments, technical queries, change requests, and validation documentation. This includes the use of electronic systems applicable to all Almac sites.
Provides oversight for customer-requested audits of Almac, communicating audit results to management and ensuring prompt and appropriate response to deficiencies and technical queries.
Deputizes for the Director of Quality, as necessary.
Qualifications:
Required Experience / Education:
Bachelors Degree in Science
3-Year Leadership Role
2-Year with Direct Reports
3-Year Quality Systems
3-Year Change Control
Packaging or Manufacturing Current Good Manufacturing Practices (cGMP)
Preferred Experience / Education:
A degree in biology, pharmaceutical, or chemical sciences is preferred
5 Year Quality Assurance/Control
5-Year Packaging/Manufacturing
5-Year Validations
1-Year Supervision
Packaging of Clinical Supplies
Global Regulatory Requirements
Training
Quality Auditing
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
- Hybrid work available for applicable roles
- 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.
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 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 ADARequest@almacgroup.com to request assistance.
Salary : $125,000 - $150,000
