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Associate Director, External Quality Control
2 months ago
Overview
Iovance is seeking an Associate Director, External Quality Control to provide strategic, technical, and operational leadership for external QC-related activities. The Associate Director will provide oversight of external testing vendors, build and maintain business continuity plans, support methods transfers to external vendors, and perform technical feasibility assessments, for the Company's cell therapy and biotherapeutic assets.
Essential Functions and Responsibilities
- Lead selection and oversight of contract QC laboratories including technical due diligence, routine performance management, and audits to ensure sustained quality analytical deliverables.
- Establishing appropriate business continuity plans for external testing vendors of raw materials and final drug product.
- Establishing a harmonized approach to external vendor method development and transfer that ensures the transition and implementation of methods fit for phase appropriate QC support.
- Develop phase-appropriate QC capabilities, business processes, and procedures.
- Support external method transfers, method qualifications and validation.
- Ensure continued alignment of internal and external cGMP analytical procedures and guidance’s supporting the Company’s cell therapy products for clinical trials, including setting of specifications, test methods, method data trending and investigations.
- Support compilation of Regulatory filings IND’s, BLAs and serve as subject matter expert in audits/meetings with Regulatory bodies.
- Ensure that QC is aligned with all internal and external CMC stake holders.
- Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the QC function remains in compliance with applicable company requirements and global regulations.
- Additional responsibilities as required.
Required Education, Skills, and Knowledge
- Bachelor’s degree in biological sciences (or relevant discipline)
- Minimum (10) years of relevant experience
- In-depth technical and regulatory understanding of biologics, gene, or cell therapy QC, with a deep understanding of the control strategies for these drug classes.
- Proven leadership experience and people management skills
- Excellent written and verbal communication skills
- Experience with regulatory submissions and inspections with an emphasis on products approved for commercial distribution
- Strong collaboration, team-building, and organizational skills are required; proven ability to effectively develop, communicate, and gain support for execution of plans and strategies with a wide range of stakeholders.
- Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills, and excellent interpersonal, organizational, and written and oral communication skills.
- Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables.
- 10% travel
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
Mental
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines
Work Environment
This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
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