Location: Buena, NJ
The Senior Manager of Quality Assurance is responsible for all Quality Assurance functions in support of sterile and topical product manufacturing and testing. The individual will be a change agent with experience building and strengthening Quality Systems and processes across all departments of the company. The Senior Manager will oversee document control, batch release, In-Process Quality Assurance, complaints and compliance, including SOPs, Validation/Qualification documentation and change control, for the Buena manufacturing site.
- Oversee all functions of the Quality Assurance area
- Build and strengthen all required processes and controls necessary for manufacture and testing of sterile and topical pharmaceutical products in an FDA-regulated facility
- Responsible for contacting the appropriate resources to make critical quality decisions if required
- Manages the site Compliance to GMP requirements for Sterile and Topical manufacture
- Oversee the maintenance of SOPs, including collaboration with the Quality Management System
- Manage the Facilities and Equipment Change Control system
- Manage the issuance and reconciliation of labeling as per cGMP
- Represent QA in the review of Qualification and Validation documentation
- Manage the resources to review of batch records for errors and completeness
- Conduct and assign personnel for the systematic audit of plant activities to determine if in compliance
- Manage the maintenance and issuance of Compounding Batch Records and Packaging Line Batch Records as required to maintain current cGMP compliance.
- Oversee the investigation of customer complaints, CAPAs, deviations and investigations
- Oversee the finished product retain system
- Oversee final disposition of CMO supplied products for Teligent Pharma to US Markets
- Oversee the creation of Annual Product Review Reports for all products
- Manage training records for the quality assurance unit.
- Manage the site’s document control system, including Master Batch Records, Standard Operating Procedures, Component Specifications, Validation Protocols, Calibration Records and other documents supporting submissions to the Food and Drug Administration
- Establish and maintain systems and processes for the documentation of validation activities for Methods, Cleaning Methods, Processes and Computerized system such that these systems are compliant to applicable regulations
- Provide support for maintaining training files for employees to ensure compliance with applicable regulations
- Bachelor’s Degree in science, engineering, pharmacy or similar area
- At least 10 years of experience in quality in regulated industry (pharmaceuticals or medical devices) is required with Sterile Manufacturing preferred
- At least 4 years of experience in technical writing to include the development of batch records, validation protocols or other similar documentation
- Experience in Quality Management Systems, Document Management Systems and LIMS.
- Proven experience as a change agent building robust processes and controls for a quality assurance organization
- Superior demonstrated ability to work on multiple projects and meet timelines
- Expert knowledge of cGMP requirements
- Significant experience with document control, and QA support of manufacturing
- Strong knowledge of Microsoft Word, Excel and Acrobat (PDF) documentation systems
- Excellent organizational skills. Demonstrated ability to work on multiple projects and meet timelines.
- Proven ability to be detail-oriented
- Able to work independently and without supervision
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities.
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Highly developed analytical and problem-solving skills to identify problems and work across functional areas for resolution
- Excellent proficiency in cGMP and regulations for topical and sterile pharmaceuticals
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.