Director of Quality
- Expired: over a month ago. Applications are no longer accepted.
Annovex Pharma is a 503b Outsourcing Facility dedicated to providing our customers with uncompromising quality, reliability, and service in meeting their compounded sterile and non-sterile pharmaceutical product needs. Our employees enjoy a work culture that promotes innovation, integrity, honesty, accountability, fairness, and fun.
We are seeking a highly motivated self-starter to join our company as a full-time Quality Director. This team member will provide leadership and guidance to our Chemists and Microbiologists to ensure all work including, testing is done as efficiently and effectively as possible. This team member will provide leadership within the Chemistry and Microbiology departments to meet cGMP regulations, as well as to drive development and validation of analytical methodologies, maintain, monitor, and optimize the stability program, and lead the analytical testing of raw materials and finished products.
This team member will lead control testing, research and development activities as needed, assist with additional work duties or responsibilities as evident or required, and will help develop guidelines for the department. Perform other duties as assigned.
The ideal candidate must have in depth knowledge and experience in a cGMP/ GLP testing lab, including significant expertise in chromatographic technologies. The Individual in this role will lead the infrastructure management and ensure the high throughput while maintaining quality requirements in Chemistry Laboratory. This individual will also provide guidance and development to the managers and supervisors of specialty teams within the Chemistry and Microbiology departments.
This position is based in Lorton, Virginia.
- Oversee the development, validation, and verification of analytical methods for raw materials, in-process control, intermediate drug product and finished drug product testing.
- Oversee the identification and address technical and validation gaps in analytical methods and ensure continuous improvement to ensure efficient testing models
- Participate in regulatory inspections as SME and develop responses to observations
- Maintain, monitor, and optimize the stability program for finished products.
- Analyze stability studies to determine appropriate shelf life and specifications for drug product.
- Manage and improve Chemistry Lab logistics activities including sample management, test/release schedule, cycle time matrix, capacity management and LIMS, etc.
- Manage outside contract laboratory relationships, including method validations, investigations, audits, cost, and invoices to meet project timelines and business requirements.
- Oversee and support OOSs/OOTs and other lab investigations, deviations, CAPAs, change controls, audits, and training.
- Purchase, calibrate and qualify Chemistry laboratory equipment systems and software (e.g., Empower, LIMS, etc.) to meet the compliance (data integrity) requirements and project timelines.
- Oversee the DEA compliance and improve controlled substance handling efficiency (e.g., samples, waste, and inventory process, etc.).
- Identify continuous improvement projects to increase lab operation efficiency, reduce paperwork and cycle times including the readiness for Rapid Micro applications.
- Oversee LIMS development, implementation, operation, troubleshooting and maintenance
- Oversee laboratory safety program to provide the analysts a safe working environment and ensure laboratory meet the safety requirements.
- Represent Chemistry & Microbiology labs to communicate in daily site huddle meetings daily shift meetings, weekly production meetings, biweekly DAR/MOC/CAPA/OOS/LEI/Deviation meetings.
- Develop, implement, and present metrics for monitoring of lab operations, stability program and analytical characteristics of the finished products
- Hire and develop team members, identifying those with leadership potential, conduct performance review and disciplinary actions.
The successful candidate will have:
- Familiarity with regulatory requirements for a 503B Compounding Outsourcing Facility, or applicable experience in sterile pharmaceutical, medical device, or biotech manufacturing.
- Detailed knowledge & understanding of cGMP, ICH, FDA, USP, DEA regulations or guidelines.
- Leadership, critical thinking and decision-making, effective communication, customer focus, business astuteness, process orientation and risk management skills.
- Proven ability to work cross-functionally to achieve business outcomes.
- Extensive knowledge of Analytical Chemistry theory (especially chromatographic separations by UPLC/HPLC) and the operation and troubleshooting analytical laboratory equipment.
- Expert-level understanding of technologies and practices for regulated quality labs preferred.
- Strong troubleshooting skill for analytical chemistry methods, including uPLC, HPLC, AA, Karl Fisher, Sub-visible particulate, and related equipment issues
- Experience in handling control substances in cGMP environment
- Strong scientific technical writing including authoring SOPs or technical/investigational reports
- Ability to work effectively under high pressure with multiple deadlines.
Expertise: Knowledge & Skills
- Require breadth of organizational, professional field, and industry knowledge. Ability to integrate critical information from several diverse areas. Champion advanced strategies and concepts.
- Direct the activities of a broad functional area through division heads who are responsible for planning, budgeting, costs, methods, and employees. Determine actual organizational structure and allocation of resources.
- Judgement is required in resolving complex problems based on experience.
- Consult senior executive management / group board members of Annovex on company-wide initiatives and act as spokesperson on matters regarding policy, capability, and strategy to the organization.
- Legally authorized to work in the United States
- Advanced degree in Chemistry, Analytical Chemistry, Microbiology, or a related field with at least 10 years relevant experience.
- Minimum of 5 years of leadership/management experience.
- Experience with sterile injectables highly desirable.
- 5 years of experience in Microbiology, preferably in pharmaceutical manufacturing
- Previous training and experience in environmental monitoring, sampling, and laboratory microbiology (USP 71, Growth Promotion Testing, Methods Validation)
- In-depth knowledge of environmental monitoring, sampling and the microbial testing and microbial method validation requirements. Experience with Rapid Microbiological testing methods a plus.
- Thorough understanding of 21CFR Part 211 cGMP requirements for sterile drug products with emphasis on 2004 Guidance for Sterile Drug Products produced by Aseptic Processing.
Annovex Pharma, Inc benefits include health care, life insurance, AD&D, paid time off, retirement savings and professional development. Employees can also take advantage of several corporate discounts.
Annovex Pharma LLC is an Equal Opportunity Employer. Employment opportunities at Annovex Pharma LLC are based upon one's qualifications and capabilities to perform the essential functions of a particular job. All employment opportunities are provided without regard to race, religion, sex (including sexual orientation and transgender status), pregnancy, childbirth or related medical conditions, national origin, age, veteran status, disability, genetic information, or any other characteristic protected by law.
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