Quality Systems Director
POSITION OBJECTIVE: Provide Quality Assurance support for life-cycle management of products marketed by Athenex Pharmaceutical Division. Proactively support the existing quality systems as necessary including writing policies and procedures, change control of GMP documentation, training, product complaint support, product launch support and bench marking cGMP requirements to decrease the likelihood of action resulting from a regulatory inspection.
Essential Job Functions/Responsibilities
· Review, compile, track and trend information in support of company compliance for Annual Product Reviews for each product marketed by Athenex Pharmaceutical Division within the required time frames as set per internal procedures. Includes communication with internal departments as well as Contract Manufacturing Organizations to obtain the necessary information to complete Annual Product Reviews.
· Provide Quality Assurance guidance and support including writing, reviewing and updating of procedures and policies including the completion of change control documentation, assisting in the distribution and collection of training for new/revised internal procedures. Support the Management Review system as requested by compiling, tracking and trending of information related to quality systems.
· Manage the product complaint program as needed in assisting with collecting information from complainants, relaying information to Contact Manufacturing Organizations, coordinating/writing investigations, and written communications with complainants.
· Manage the change control program for internal and external changes.
· Support new product launches for the branded business, including Process Validation oversight and execution of packaging performance and shipping studies.
· Act on behalf of the Vice President Quality Assurance, as directed.
Required Education & Qualifications
· BS Degree with 10 years of progressive challenging QA/QC experience in the pharmaceutical industry.
· In-depth knowledge of current GMP and GLP as well as FDA trends and guidelines.
· Strong interpersonal communication skills required – verbal, written and presentation.
· Ability to work in a cross-functional team environment and a flexible team-oriented perspective
· Must have excellent organizational and management skills to coordinate multiple projects.
Proficient with PC-based word processors, databases and spreadsheets.
· In-depth knowledge of current GMP and GLP as well as FDA trends and guidelines with a focus on injectable products.
· Possesses strong organizational skills for prioritizing workload and responsibilities.
· Strong (written and verbal) communication, interpersonal, negotiations and problem solving skills required.
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.