Associate Director, QA Audit in Basking Ridge, New Jersey at DSI

Date Posted: 2/3/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years & Counting!

With over 100 years of scientific expertise & a presence in more than 20 countries, Daiichi Sankyo & its 15,000 employees around the world draw upon a rich legacy of innovation & a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension & thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research & development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart & kidney diseases, & other rare diseases.

Job Summary:
Accountable to organize & direct an audit universe for GMP relevant activities involving but not limited to supplier qualification program, CMC audit, clinical/IMP vendor audits & overall GMP vendor audit program. Establish lessons learned from audits/inspections to drive improvement in collaboration with other QA functions &/or applicable stakeholders. Support/ lead & or co lead due- diligence assessments of GMP facilities & or CMOs as necessary. Ensure inspection readiness is adequately performed & may support &/or lead regulatory inspection activities at DS facilities &/or CMOs. Demonstrate ability to support the transformation of the organization into a learning & proactive organization through lessons learned from audits, assessments, inspections, metrics, deviations & or process improvements. Ensure 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 & teamwork.

Responsibilities:
GMP Audit: Lead & direct an audit universe for all audit types (facility, vendor, third party, internal systems etc.,) be accountable to establish the audit strategy in conformance with current GMP regulations & guidelines, best industry practices & DS QA Global Standards. Includes the use of related IT systems for overseeing GMP audit program. Define/review audit plan, schedule/perform presential or paper-based audits, evaluate/classify findings, write reports, review & judge the responses & applicable measures to ensure an appropriate track for corrective & preventive actions implementation. Properly store/retain records in order to ensure the traceability for Audit process. Define, review & comply with specific risk management tools to address the risks at each audited company & the required compliance level as per ICH Q9. Support development of GMP audit certification program to ensure adequate qualification of auditors per regulatory expectations.

GMP Inspection Readiness: Supports & leads GMP mock &/or pre-approval inspection activities for DS &/or CMO involved in drug product manufacturing, testing & warehousing activities. Participate with sites before, during & after regulatory inspections to ensure acceptable results & on time delivery of CAPAs from regulatory inspections. Assure observations made during audits & regulatory inspections are addressed.

Audit Intelligence & Metrics: Responsible to create/maintain database information about vendor & supplier Quality status defining, evaluating & communicating periodically metrics to DSI QA involved functions & DS Global QA organization for each audit type, quality events, &/or vendor & supplier Quality status. Exercise a level of leadership necessary to influence the organization into learning from audit intelligence & metrics. Engagement with GMP QA quality managements, Pharma Product QA teams & other QA functions as necessary to ensure communication of metrics, lessons learned from audits & to ensure that are used for continuous process improvement & stakeholder management. Ensure proactive assessment of suppliers prior to selection & contract. This may include the need to set up standards for pre-selection of vendors &/or suppliers to meet DS company expectations

Development of Standards & Procedures (SOPs) & Training: Authoring procedural documents that set strategy in QA GMP Audit processes in collaboration with GMP Quality System function. Support development & implementation of key global/regional QA GMP Standards, Procedures & Instructions. Responsible to train QA GxP related functions in best auditing practices to ensure the inspection readiness level of each site & maintain a capacitation program for GMP staff in best audit skills.

Cross-Functional Team Participation: Collaborate with QA GMP organization participation in local, regional/global audit activities which includes mock pre-approval inspections, routine ongoing GMP compliance audits & GMP regulatory inspections. Support the establishment, standards definition, training & capacitation program for GMP QA Auditors.

Communication: Communicate clearly & in a timely manner with suppliers in order to address & identify proactive solution for business contribution, resolves complex issues & difficult stakeholder management situations. Responsible for evaluating the impact & properly communicate with management in order to proactively recognize risks & provide good solution. Lead & influence proactively without “policing”. Create an atmosphere of trust, integrity & ethics. Ensure full stakeholder management & engagement through establishing of quality review boards/GMP quality council to ensure quality topics &/or complex issues are effectively addressed. Demonstrates influential skills to drive the level of productivity, results & leadership necessary to transform the GMP QA audit teams & or GMP cross functional teams as a learning organization.

Budget Management: Adhere to annual budget to manage expense expectations & 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 level preferred.
  • Minimum 7 yrs in pharmaceutical, biological &/or medical device operations including first-hand knowledge of drug manufacturing, packaging, QA, compliance & audit. Experience with various pharmaceutical dosage forms desired.
  • Certifications for Pharmaceutical Quality Engineering, Auditing &/or Quality Management (Preferred but not required)
  • Direct experience dealing with multinational drug regulators.
  • Solid understanding of quality management & 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.