Senior Manager Quality Assurance

Location: Buena, NJ

Job Summary

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.

Essential Responsibilities

  • 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

Qualifications

  • 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.

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