Manager/Sr. Manager, Quality Assurance

Locations: Cranbury, NJ

Functions: Quality Assurance and Compliance

Novelstar Pharmaceuticals Inc. (A Fosun Pharma Company) is hiring a Manager/Sr. Manager, Quality Assurance, to be located in Cranbury, NJ. If you are looking for a great pioneer opportunity to develop your career, be empowered to take charge of your future at Novelstar.

Novelstar Pharmaceuticals, Inc. is a Fosun Pharma (Fosun Pharmaceutical (Group) Co., Ltd) company. Our mission is to develop novel pharmaceutical drug products (NDA), deliver high quality generic products (ANDA) and provide service to pharmaceutical industry. Our vision is to be a robust growth innovation leader and partner in global healthcare to enhance people`s lives.

The Manager/Sr. Manager, Quality Assurance will lead and maintain a QA system in Novelstar, ensure the site is in full compliance with regulatory, industry, Novelstar requirements and standards. Plans, coordinates, leads and/or facilitates internal and external audits and provides support during regulatory visits.

Lead quality programs and provides quality review, guidance and recommendations associated with all the projects developed in Novelstar or CMOs. The QA Manager/Sr. Manager is responsible for ensuring that all planned and unplanned quality & compliance issues are addressed.

·        Maintain a quality system to ensure the pilot manufacturing facility and analytical laboratory fully comply with cGMP requirements.

·        Manage and maintain a SOP system for all the Quality unit, and review and approval of SOPs for other departments.

·        Assures quality products and processes by establishing and enforcing quality standards and testing materials and products.

·        Develops raw material standards by studying manufacturing and engineering requirements, conferring and negotiating with suppliers, and devising testing methods and procedures.

·        Creates product quality documentation system by writing and updating quality assurance procedures.

·        Maintains product quality by enforcing quality assurance policies and procedures and government requirements.

·        Review CMC documents for cGMP batches, including coordinating environmental monitoring and equipment calibration, receiving and releasing raw material, reviewing and issuing master batch records, room equipment and raw material release, in process check during manufacturing, reviewing executed batch records and protocols, reviewing analytical data and releasing cGMP batches.

·        Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.

·        Manages quality metrics and drives improvements.

·        Manages inspection readiness system and activities for the site, ensuring the sites are always in an inspection ready state.

·        Plans, coordinates, leads and/facilitates internal and external audits and provides leading role support during Health authority inspections. Responsible for response efforts for health authority inspections.

·        Manages and trains employee/designee on use of Quality Systems

·        Ensures all Out of Specification / Out of Trend results are thoroughly investigated with root cause identified and appropriate corrective actions implemented.

·        Develops an Internal Audit Program, audit schedule development, and program improvement efforts and participates in or leads audits as required.

·        Participate in change controls, investigations, and corrective actions as owner, assessor or approver.

·        Approve (or develop) cGMP training materials/plans for functional areas.

·        Review and approve validation protocols and reports, equipment/facility change requests, calibration documentation.

·        Draft, edit and approve department procedures as needed and ensure document hierarchy is maintained in a logical state.

·        Carries out all duties in compliance with all local, state and federal regulations and guidelines including FDA, EMA, EPA, DEA, and OSHA and ensures that organization is equipped and complied.

·        Complies with all company policies, standards and procedures.

·        Monitors/tracks changes in regulatory environment (e.g., compendia, regulations/directives, guidance documents, global standards)

·        Manages timeliness of local investigations, Corrective Actions, Change Controls (e.g., tracks open records and assures closure)

·        Responsible for training new employees and providing mentorship, coaching, and support as needed.

·        Facilitates or participates in any and all required meetings related to quality.

·        Manages the routine Environmental Monitoring of Pilot facilities and facility Qualification as needed. Prepare/ Review and Approval of trend data for environmental monitoring.

·        Manages the Purified Water System Qualification and routine testing and release of purified water.

·        Manages the stability program and shall ensure the timeline for the testing and release of Stability Samples

·        Manages the equipment qualification program. Responsible for preparation, review and approval of risk assessment, IQ, OQ & PQ protocols and Reports

·        Manages the Raw material, In-process and Finished Products sampling, analytical raw data review and release. Responsible for reviewing and maintaining the Material Inventory management.

·        A bachelor’s degree required. Degree concentration in a scientific, engineering or related area is preferred. Advanced degree (MBA, MS or PhD) preferred.

·        Minimum of 8 years’ experience working in a regulated quality environment.

·        Experience in leading/facilitating internal and external audits and support during Health authority inspections required.

·        Ability to write and/or effectively review/critique technical documents such as lab investigations with analytical, manufacturing and regulatory content.

·        Experience in operating as a leader with global mindset, understanding and appreciation of the global /enterprise context preferred.

·        Ability to define problems, collect data, establish facts and draw valid conclusions required.

·        Ability to establish and maintain cooperative working relationships with internal and external partners required.

·        Ability to take initiative and work independently while effectively managing timelines required.

·        Ability to perform in fast paced environment and in stressful situations is required.

·        Influence, shaping solutions, negotiation and consultative skills are required.

·        Additional domestic travel and internal travel as needed.

·        Understanding of laboratory systems/equipment (e.g., IQ/OQ/PQ) is a must.

·        Expert knowledge and understanding of compendia (USP, EP, JP, etc.), global regulations, and current Good Manufacturing Practices (cGMP) pertaining to pharmaceutical laboratory operations required.

·        Advanced knowledge of Quality Lab Systems for investigations, CAPA management, change control, and document management (e.g., Trackwise, ComplianceWire) quality systems required.

·        Strong leadership skills and strategic problem-solving ability.

·        Excellent communications and presentation skills in both written and verbal; create and deliver summaries, development reports and presentations as needed.

·        Excellent organizational skills: Proactive, management of multiple tasks of varied complexity simultaneously.

·        Negotiation and strong persuasive abilities, diplomacy and positive influencing abilities.

·        Independently make difficult quality & compliance decisions required.

Locations: Cranbury, NJ

Functions: Quality assurance and compliance

Compensation:

Commensurate with experience, medical/dental/vision insurances, disability and life insurance, holidays, and paid time off and 401k.

DISCLAIMER: The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job.