Location: Buena, NJ
The Quality Operations Director will be responsible and accountable for directing the quality assurance activities, to ensure that Teligent drug products are manufactured and tested following the Regulatory filling and cGMP requirements. This position is also 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 Director 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.
- Assure that all manufacturing processes, analysis and relevant activities are in conformance with CGMP and regulatory fillings
- Assure that the GMP related documentation is in conformance with site procedures
- Organize and manage activities related to compliance initiatives at the site, managing the development, implementation and verification in accordance with Company and regulatory requirements.
- Verify, support and assure that the QA activities are in line with regulatory requirement and company procedures
- Develop and maintain the site Quality organization Budget and staffing to the level necessary to fulfill the Quality Unit responsibilities
- Lead the selection process for the Quality Assurance positions and ensure that the performance assessment of members of the quality organization are conducted
- Develop the quality organization objective consistent with the site and Corporate Quality objectives
- Organize the professional and technical training of the quality unit personnel
- Build and strengthen all required processes and controls necessary for manufacture and testing of sterile and topical pharmaceutical products in an FDA-regulated facility
- 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
- 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
- Education: Bachelor’s degree in Chemistry, Microbiology, or other Physical Sciences
- Minimum 10 – 12 years of experience in pharmaceutical QA or QC role
- Working knowledge in the quality systems for the pharmaceutical industry and medical devices
- Working knowledge in FDA 21 CFR Parts 11, 210, 211 and 820, USP and ICH quality system requirements
- Working knowledge of aseptic quality assurance, quality control and environmental monitoring
- Ability to work collaboratively in a professional and effective manner across Teligent departments
- Strong investigation and problem-solving skills
- Working knowledge of risk management
- Strong leadership skills
- Ability to delegate and verify
- Ability to manage and prioritize multiple tasks
- Ability to guide and motivate personnel
- Ability to plan and organize available resources and activities in-order to reach predefined goals
- Awareness of inter-personnel relationships in the company
- Experience in using computer programs (MS Word, Excel, and Access)
- Strong verbal and written communication skills
- Willingness to travel – up to 10% (Nationally and internationally)
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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