Manager/Associate Director, Quality Assurance

Locations: Cranbury, NJ

Functions: Quality Assurance and Compliance

Job description

Novelstar Pharmaceuticals Inc. (A Fosun Pharma Company) is hiring a Manager/Associate Director, 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 the pharmaceutical industry.  Our vision is to be a robust growth innovation leader and partner in global healthcare to enhance people`s lives.

The Manager/Associate Director, 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/Associate Director is responsible for ensuring that all planned and unplanned quality & compliance issues are addressed.

Key Responsibilities include but are not limited to:

  • Establish and maintain a quality system to ensure the design and construction of a new pilot manufacturing facility and analytical laboratory in fully complying with cGMP requirements.
  • Manage and maintain an SOP system for all the Quality units, and review and approve 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.
  • Collaborates with other members of management to develop new product and engineering designs and manufacturing and training methods.
  • 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 the 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 the organization is equipped and complied with.
  • Complies with all company policies standards and procedures
  • Monitors/tracks changes in the 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

Qualifications and Requirement

  • A bachelor’s degree is required. Degree concentration in a scientific, engineering, or related area is preferred. Advanced degree (MBA, MS, or Ph.D.) preferred.
  • Minimum of 8-year experience working in a regulated quality environment with a minimum of 3-year experience directly leading people required.
  • Experience leading/facilitating internal and external audits and provides leading role 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 operating as a leader with a 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.
  • The ability to perform in a 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 required ~20%.

Knowledge and Skills

  • Understanding 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 needs.
  • Excellent organizational skills: Proactive, management of multiple tasks of varying 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,

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