Sr. Director, Clinical Quality Assurance
Reports to: Senior Vice President of Quality
Date: August 20, 2018
The Sr.Director, Clinical Quality Assurance, oversees the development, implementation and maintenance of quality assurance systems and activities under the leadership of the Sr. Vice President of Quality. S/he is responsible for companywide compliance with GXPs. In this role, s/he oversees generation and review of documents used in good manufacturing practices, good clinical practices, good laboratory practices, and good vigilance practices. Duties include primary QA oversight of clinical and non-clinicaloperations, participation on study execution teams and coordination of interdepartmental activities, leading investigations and resolving potential product quality issues to improve efficiency, and assuring compliance in conduct of clinical and nonclinical studies.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· Ensure the compliance of contract manufacturing and testing activities with respect to company procedures as well as FDA, EU, ICH, and other regulatory expectations and requirements by interacting/managing the GMP QA manager
· Ensure the compliance of contract research organizations in the conduct of clinical and nonclinical trials.
· Ensure batch record review and lot disposition activities for intermediates, drug substance and drug product, including review of analytical data, testing records, and stability data.
· Ensure implementation of the Quality Systems and procedures (document control, auditing, change control, corrective and preventive actions, deviations, investigations, vendor qualification, etc.) and pursue continuous improvements throughout the organization.
· Manage and ensure the maintaince of the employee training program
· Excellent problem solving and communication skills.
· Provide guidance and mentoring to direct reports.
· Ability to interface with all levels of management.
· Promote quality culture throughout the organization
· Identify and implement continuous improvement initiatives that seek to eliminate inefficiency, reduce cost and improve product quality.
Managing and measuring work
Motivating Others – creates a climate in which people want to do their best
Strong organizational, planning, problem solving, and decision-making skills.
Excellent written and verbal communication skills and collaborative working style.
Ability to work independently and keep management updated.
This position has supervisory responsibilities. Reporting into this position will be a Quality Assurance Manager, GMP.
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
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.
While performing the duties of this job, the employee is regularly required to talk or hear. This is largely a sedentary role; however, some filing is required; it would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.
Position Type/Expected Hours of Work
This is a full-time position. The typical workweek is five eight-hour days, Monday through Friday. Occasional evening and weekend work may be required as job duties demand.
Some travel time, approximately 30%, is expected for this position.
Required Education and Experience
- Bachelor’s Degree in physical/life sciences
- Eight or more years of Quality Assurance experience in the pharmaceutical or biotech industries required.
- Knowledgeable in ICH/cGMP/GLP/GCP, and regulatory guidelines as applied to the entire development lifecycle of biotech and pharmaceutical companies, with special emphasis on GCP requirements and regulations.
- Experience with the qualification and implementation of Part11 compliant systems.
- Experience with electronic document management system (EDMS).
- Flexibility and willingness to multitask and change priorities in a dynamic environment.
Additional Eligibility Qualifications
- Computer proficiency and technical aptitude with the ability to use Microsoft products.
- Proven ability to work effectively in a team environment with associates. Capability of effective planning and priority setting. Ability to manage several complex projects simultaneously while working under pressure to meet deadlines.
Equal Employment Opportunity Employer
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.