Assoc Dir, Quality Control

**Associate Director, Quality**
- Jubilant Cadista Pharmaceuticals, Inc., located in Yardley, PA, is a Jubilant Life Sciences Company, a global healthcare company with a wide range of products and advanced technologies. Our strong product development teams and advanced supply chain has enabled us to build a very strong position in a competitive market._

Position Summary

To provide hands-on, tactical management of daily activities of Quality Assurance.

Essential Functions
- (Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills and other characteristics. This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be_ assigned.)_
- Acts as the primary contact with Regulatory agencies for the purpose of inspections for JGL products
- Manage the Quality Assurance functions and workload and completes or review tasks within Quality Assurance and Quality Control
- Provides Quality Oversight of CMO’s
- Maintain quarantine/release/reject system for raw materials, labeling materials, and finished drug products
- Perform vendor and internal audits.
- Review batch records and disposition product to the market.
- Manage the Quality Management Systems (TrackWise, ComplianceWire, MasterControl, etc.)
- Review and approve documents including but not limited to investigations, CAPAs, change controls, complaint and OOS investigations, as well as batch manufacturing records, stability studies, Annual Product Quality Reviews
- Maintain a thorough knowledge of appropriate standard operating procedures.
- Serve as a resource to contract manufacturing organizations and testing services providers that manufacture and/or test JGL products
- Maintain and inspect retention samples
- Manage the complaint, deviation, change control, CAPA, OOS/OOT processes.
- Oversight of the Recall process
- Monitor and audit manufacturing for cGMP compliance.
- Train Quality Assurance staff.
- Perform personnel evaluation as needed.

Experience and Qualifications:

- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the experience and qualifications required:_- Education
- Bachelor’s Degree in Chemistry or related field.

Industry Experience Required
- Five (5) to ten (10) years of relevant experience in the pharmaceutical industry.
- Three (3) to five (5) years of managing experience.

Knowledge, Skills and Abilities:

- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required_:
- Knowledge
- Demonstrated excellent knowledge of cGMP’s.
- Communication Skills
- Proficient verbal and written communication skills- Computer Skills- Reasoning Ability
- Proficient observation skills and attention to detail

Working Environment
- The working environment demands of this job are physically and environmentally centered on characteristics and abilities involved in this work. The work environment considers the risks and discomforts in the physical surroundings and the nature of the work assigned to ensure that all safety regulations and techniques required to perform the job are precautions practical to eliminate all risks._

PhysicalWork is regularly performed inside in an office and manufacturing environment.
- The work area would be an office space generally involving a work desk and a computer.
- Extensive word processing and data entry work on computers will be involved.
- Interaction with other departments including Manufacturing, Quality Assurance, and Quality Control, and Product Development and Technical Services with respect to documentation will be involved.
- Frequent sitting, talking, or hearing.
- Use hands to finger, handle, feel, or operate objects or controls.
- Reach with hands and arms.
- Walk short distances.
- Exposure to dust, odor, noise, fumes
- The noise level is usually moderate

**~ Compensation based on experience ~**

**~ Jubilant Cadista offers an excellent benefit package which includes but is not limited to Health, Vision, Dental, 401K ~**

**~ Relocation assistance available if relocation is required ~**
- It is the policy of Jubilant Cadista Pharmaceuticals, Inc. (herein “Cadista”) to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sexual orientation, gender identity and/or expression, marital status, status as a disabled veteran and/or veteran of the Vietnam Era or any other characteristic protected by federal, state or local law. In addition