Associate Manager/Manager, Quality Assurance

Granules Pharmaceuticals, Inc.; Manassas (VA); On-site; USD 85,000 - 100,000; Full time

Job summary

Granules Pharmaceuticals Inc. in Manassas, VA, is seeking an Associate Manager / Manager, QA to ensure cGMP compliance across all quality system functions. The role oversees document control, CAPA, change control, investigations, and training to support timely product disposition and release.

The candidate will mentor QA staff, coordinate internal and external audits, and collaborate with Regulatory Affairs for FDA filings while maintaining training and quality systems at the Manassas site.

Job description

Granules Pharmaceuticals Inc., (GPI) is a subsidiary of Granules India LTD. Over the past 34 years, we have worked towards strengthening our core and we are currently the 10th fastest growing generic pharma company in the US!

With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform.

We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options.

*This is an Onsite Role**

The Associate Manager / Manager, QA ensures compliance with cGMP and internal policies, procedures and specifications. This position is responsible for performing documentation for all quality system functions in accordance with cGMP and related company SOP’s, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines.

The person will be responsible for managing and ensuring that facility meets all GMP, FDA and SOP requirements.
Managing all quality operations to include inspection of components, bulk, and final products for the Manassas, VA, ensuring release lead times are met with timely product disposition.
Ensure that the facility is meeting all training requirements.
Lead the communication of open quality document notification and resolution between all departments regarding Complaints, Investigations, Change Control, CAPA’s (including verification of CAPA’s) and other quality documents as needed.
Manage and maintain audit inspections (Internal and External) for the site.
Responsible for supporting the preparation, review, processing, and approval of various validation documents as application for the Granules, Manassas, facility.
Provide QA support, review and approval for relevant documents including relevant procedures, batch records, specifications, stability reports, technical reports (i.e., Qualification, Validation, Transportation.), trend reports, Annual Product Quality Reviews and other documents as needed.
Responsible for performance and development of all Quality Assurance staff through mentoring and focusing on personal and professional growth.
Work with Quality leadership team for proactive succession planning and a high-performance culture through people.
Guide and lead by setting realistic personal goals for staff and provide regularly scheduled feedback throughout the year.
Provide the means for incorporating the necessary tools, equipment, and methods into the new and existing processes aimed at continuous improvement.
Implementation Quality management system tools and their compliance.
Development and execution of quality training modules for the organization.
Ensure staff receives appropriate knowledge and skill development and growth opportunities
Work with Regulatory Affairs to supply information needed for FDA filings.
Other duties as assigned by management.

Requirements

Knowledge & Skills

Expert-level knowledge of the FDA guidance for Industry, Title 21 of the Code of Federal Regulations and Compendia (USP/EP/BP/etc...)

• GMP compliance within the pharmaceutical manufacturing industry.
• Writing and maintaining cGMP documentation.
• Analyze data/information and resolve complex issues.
• Verbal and written communication skills.
• Work and communicate with cross-functional teams.
• Multiple priorities and re-prioritize tasks.
• Strong computer skills and working knowledge of Microsoft Office Suite and Adobe
• Demonstrated ability to work on complex assignments in collaboration with various departments.

Experience & Education

Bachelor's degree in the life sciences (or equivalent work experience) minimum of 6+ years in a QA role within the pharmaceutical industry
Master’s degree with 4+ years of pharmaceutical manufacturing experience and at least 3 years of those years in a progressive challenging QA department in the pharmaceutical industry.

Physical Requirements/Working Environment

While performing the duties of this job, the employee is regularly required to, stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone keyboard.
Specific vision abilities required by this job include close vision requirements due to computer work.
Ability to sit at a computer terminal for an extended period of time.
Light to moderate lifting up to 10-15 lbs is required.
Ability to work in a confined area

Salary Description

$85,000 - 100,000