Associate Director, QA Audit

Location
Basking Ridge, NJ
Posted
Oct 28, 2021
Ref
10959BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Contract

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:


Accountable to organize and directs an audit universe for GMP relevant activities involving but not limited to supplier qualification program, CMC audit, clinical/IMP vendor audits and overall GMP vendor audit program.  Establish lessons learned from audits/inspections to drive continuous improvement in collaboration with other QA functions and/or applicable stakeholders. Support/ lead and or co lead due- diligence assessments of GMP facilities and or CMOs as deemed necessary.  Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or CMOs.
 
The incumbent will have to demonstrate ability to support the transformation of the organization into a learning and proactive organization through lessons learned from audits, assessments, inspections, metrics, deviations and or process improvements. Ensure adequate QA oversight of the GMP audit programs of contract manufacturing sites/ warehousing/ specialty pharmacy as necessary. Ensure effective collaboration with DS affiliates to promote a culture of quality that drives performance and team work. 
 

Responsibilities:
Lead and directs an audit universe for all audit types (facility, vendor, third party, internal systems etc.,) being accountable to establish the audit strategy in conformance with current GMP regulations and guidelines, best industry practices and DS QA Global Standards. This also includes the use of related IT systems for overseeing GMP audit program. Define and review audit plan, schedule and perform presential or paper-based audits, evaluate and classify findings, write reports, review and judge the responses and applicable measures to ensure an appropriate track for corrective and preventive actions implementation. Properly storage and retain all the records in order to ensure the traceability for Audit process. Define, review and comply with specific risk management tools to address the relevant risks at each audited company and the required compliance level as per ICH Q9. Support the development of GMP audit certification program to ensure adequate qualification of auditors per regulatory expectations.
 
Supports and leads GMP mock and/or pre-approval inspection activities for DS and/or CMO involved in drug product manufacturing, testing and warehousing activities. Participate with the sites before, during and after regulatory inspections to ensure acceptable results and on time delivery of CAPAs from regulatory inspections. Assure that all observations made during audits and regulatory inspections are addressed in a timely manner.
 
Responsible to create and maintain database information about each vendor and supplier Quality status defining, evaluating and communicating periodically metrics to DSI QA involved functions and DS Global QA organization for each audit type, quality events, and/or vendor and supplier Quality status. Exercise a level of leadership necessary to influence the organization into learning from audit intelligence and metrics. Effective engagement with GMP QA quality managements, Pharma Product QA teams and other QA functions as deemed necessary to ensure communication of metrics, lessons learned from audits and to ensure that are used for continuous process improvement and stakeholder management. Ensure proactive assessment of suppliers prior to selection and contract. This may include the need to set up standards for pre-selection of vendors and/or suppliers to meet DS company expectations
 
Responsible for authoring procedural documents that set strategy in QA GMP Audit processes in collaboration with GMP Quality System function. Supports the development and implementation of key global/regional QA GMP Standards, Procedures and Instructions. Responsible to training QA GxP related functions in best auditing practices in order to ensure the inspection readiness level of each site and maintain a capacitation program for GMP staff in best audit skills.
 
Collaborate with QA GMP organization participation in local, regional and global audit activities which includes mock pre-approval inspections, routine ongoing GMP compliance audits and GMP regulatory inspections. Support the establishment, standards definition, training and capacitation program for GMP QA Auditors.
 
Communicate clearly and in a timely manner with suppliers in order to address and identify proactive solution for business contribution, resolves complex issues and difficult stakeholder management situations. Responsible for evaluating the impact and properly communicate with management in order to proactively recognize risks and provide good solution. Lead and influence proactively without “policing”. Create an atmosphere of trust, integrity and ethics. Ensure full stakeholder management and engagement through establishing of quality review boards/GMP quality council to ensure quality topics and/or complex issues are effectively addressed. Demonstrates influential skills to drive the level of productivity, results and leadership necessary to transform the GMP QA audit teams and or GMP cross functional teams as a learning organization.
 
Adhere to annual budget to manage expense expectations and provide fiduciary oversight to the QA function.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
 
Education/Experience:

Bachelor's Degree in scientific discipline required
Master's Degree preferred
7 + Years in pharmaceutical, biological and/or medical device operations including first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit preferred
7 + Years experience with various pharmaceutical dosage forms preferred
Certifications for Pharmaceutical Quality Engineering, Auditing and/or Quality Management
Direct experience dealing with multinational drug regulators. 
Solid understanding of quality management and continuous process improvement principles including global cGMP requirements.

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.