Senior Quality Assurance Manager
POSITION OBJECTIVE: Provides leadership to the Quality Assurance team and oversees cGMP compliance for our Dunkirk, NY manufacturing facility.
Essential Job Functions/Responsibilities
- Ensures compliance for all aspects of Athenex cGMP Operations.
- Lead the Quality team in their development and continuous improvement.
- Develop strategies and translate these into realistic projects utilizing Quality Assurance as well as Manufacturing resources.
- Develop and maintains proactive communication with all applicable territories/regions regarding meeting quality standards, anticipating future requirements and interpreting customer expectations.
- Development of quality improvements, including validation, systems and documentation, together with ensuring the maintenance and implementation of such improvements.
- Participate in developing global quality standards to meet both regional and international requirements alongside both local and corporate team members.
- Assist in quality related issues as they impact manufactured product, utilized raw materials and analytical testing to assure released products possess the required potency, purity and conformance to established specifications.
- Author FDA Field Alert Reports and Recall Notifications as needed.
- Maintain the necessary regulatory registrations in accordance with state, federal and global requirements.
- Hosts/leads site visits from customers and regulatory bodies for the purposes of auditing/inspecting site compliance.
- Develop corrective actions based on relevant audit observations and engages site subject matter experts for support.
- Develop and maintain a system for reporting site metrics in accordance with regulatory and local management requirements.
- Drive discussion with Quality Review Board for establishing a roadmap for strategic quality improvements and priorities.
- Champion the philosophies of applying 'state of the art' quality to all levels of operations, promoting ownership and correct attitude to achieve a 'right first time' performance.
- Develop resources planning for quality systems management and improvements.
- Promote and implement staff training, motivation and personnel development.
- Complete staff assessments and salary reviews as required ensuring competencies are maintained.
- Participate in personnel development programs to further enhance skills and knowledge relevant to the position.
- Assists in the development and implementation of strategic initiatives from Quality Assurance senior management.
- May perform other duties as assigned
Required Education & Experience
- Bachelor of Science degree in Biology, Chemistry, or related science; advanced degree in life sciences field or MBA is a plus
- Minimum of 10 years of experience in progressive Quality Assurance and/or Quality Control roles in a pharmaceutical organization
- Minimum of 3 years of experience leading Quality teams in a pharmaceutical organization
- Experience with cGMP 21 CFR 210/211/820 Quality Systems.
- Direct and positive experience in communicating with Regulatory Authorities, customers, and executive management.
- Experience in CAPA, investigations, root cause analysis.
- Lean Six Sigma experience.
- Experience in implementing training, supplier management, and complaint programs.
Required Skills & Abilities:
- Ability to effective lead, coach, motivate and mentor Quality team members
- Effective communication and collaboration skills with the ability to work across multiple levels of an organization
- Performance driven with the ability to work to and achieve measurable results.
- Must have a valid drivers license for travel to other Athenex facilities
- Support quality needs that may occur after hours.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.