Associate Director, External Supplier QA GMP

Initial Therapeutics, Inc.; Basking Ridge (NJ); On-site; USD 153,600 - 230,400; Full time

Job summary

Initial Therapeutics, Inc. is hiring for a QA management role focusing on ensuring compliance within contract manufacturing operations. The role involves oversight of Quality Management Systems, partnering with quality leaders, and supporting validation efforts for drug products.

Ideal candidates will have over 7 years in the pharmaceutical sector, understanding regulatory compliance, and are expected to frequently collaborate across functional teams. The position includes travel requirements of up to 30% and offers a competitive salary range.

Qualifications

• Bachelor’s Degree in scientific discipline required; advanced degree preferred.
• 7+ years in pharmaceutical operations including knowledge of drug manufacturing.
• Experience with contract manufacturing organizations is required.

Responsibilities

• Ensure robust Quality Management System compliance with industry guidelines.
• Support drug product management and operational activities.
• Participate in cross-functional teamwork with Quality Leaders.

Skills

Knowledge of drug manufacturing

Quality management principles

Experience in contract manufacturing

Aseptic/Sterile Manufacturing

Ability to work in a project environment

Education

Bachelor’s Degree in scientific discipline

Master’s Degree or advanced degree preferred

Job description

Company Overview

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Job Summary

Accountable to lead, manage and ensure that all Contract Manufacturing, Testing and Warehousing organizations contracted by or on behalf of Daiichi Sankyo that provide services through the supply of commercial and investigational drug product is constantly assessed to comply with FDA premises and regulation, another applicable GMP guidelines and internal DS policies, procedures or standards. The incumbent is responsible to identify QA risks at CMO's and support the recommended courses of risk treatment and resolution manner in appropriate way and to ensure continuous improvement in the management of CMO risks. Interacts with DS affiliates and Headquarter to support with routine and unusual issues related with Global Products.

Responsibilities

• Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment & lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.
• Drug Product Management: Supports technically the operational activities which include API and drug product manufacturing, packaging and labelling operations, QC testing and release, and distribution for biologics and small-molecules products manufactured at CMO’s and ensures the validation requirements for all global markets are also met.
• Cross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA R&D functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations.
• Process Validation and Product Technical Transfer: Responsible for review and approval of documents associated with validation or qualification activities, risk assessment strategies, technical studies and applicable changes that may require DS support. Ensure respective compliance with applicable DSI and or DS relevant procedures, standards and instructions that affects and directs CMO activities. This position can be supportive also to oversight and QA support for product and process technology for acquired or transferred product into and out of CMO’s organizations.
• Deviation and Complaint Investigation Program: Provides support to the investigation of deviations and complaints in order to ensure a timely manner activity and a protective solution to avoid any risk to the quality and safety of commercial and investigational drug products supplied through DSI and DS affiliates.

Qualifications

• Education Qualifications Bachelor’s Degree in scientific discipline required or Master’s Degree or other advanced degree preferred.
• Experience Qualifications 7 or more years in pharmaceutical and/or biological operations including first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit. Experience with bio manufacturing and technical transfer required 4 or more years direct experience dealing with multinational drug regulators is required. Previous management experience would be preferred. Solid understanding of quality management and continuous process improvement principles including global cGMP requirements is required. Experience with Aseptic/Sterile Manufacturing and/or experience in a project environment within the pharmaceutical or biopharmaceutical industries and/or cold chain qualifications is strongly preferred. Experience dealing with contract manufacturing organizations is required.

Travel Requirements

Ability to travel up to 30% of the time.

Salary Range

USD$153,600.00 - USD$230,400.00

Equal Employment Opportunity

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.