Manage regulatory inspections, internal and external audits and paper-based inspections.
Support all required inspection preparation activities (e.g. providing necessary training to inspection support team and presenters, identification of risks, preparation of pre-request, management of logistics which include ART Room set up, SWAT team).
Assuming leadership role during an inspection.
Lead and manage post inspection response process and follow up with action owner/ team(s) to ensure inspection commitments are met per committed timelines, including communicating and coordination with global functions and/ or network sites and escalation of issues.
Independently lead and/ or execute site self-inspection program and inspection readiness activities at site to identify GMP compliance gaps/ risks.
Provide compliance expertise to the site, collaborate with stakeholders to identify and remediate compliance gaps.
Create internal audit schedule, develop audit plan/ agendas, identify audit scope and materials preparation, lead/ participate in self inspection, develop findings, write final audit report and follow up observation responses.
Support filings and submissions as requested by local PTR representatives.
Interface with Affiliates to maintain import licenses, support local Business Operations Functions to maintain and keep the necessary Wholesaler and Distribution Licenses if applicable.
Participate in cross functional project teams, collaborate effectively with and influence key stakeholders to drive site compliance improvements.
Manage Quality Compliance Scorecard (QCS) program at site, including
Actively communicating new requirements and compliance trends to site stakeholders
Following up on compliance risk mitigation actions
Create, maintain and report inspection metric/ reports/ Key Performance Indicators to monitor site’s inspection readiness health status and as required by the site and global network.
Execute supplier management program at site, responsible for
Monitoring local suppliers performance and compliance with cGMP requirements and applicable regulations
Performing supplier audits of locally managed suppliers,
Serve as the primary point of contact at site and interface and collaborate with global SQM team
Support qualification of Site Services Providers with GMP impact.
Management and maintenance of Quality Agreements, in collaboration with key stakeholders.
Developing others by coaching/mentoring less experienced employees and/ or interns.
Who You Are
Bachelor’s degree required (in a Science or technical field such as Pharmacy, Life science, Biology, Biochemistry, Chemistry or Engineering is preferred)
Graduate or higher level Degree is preferred
7 or more years’ quality, compliance or other relevant experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experiences.
Advance knowledge of Quality System principles, practices and standards for the pharmaceutical industry.
Strong analytical mind, with the ability to interpret and relate Quality standards for implementation and review.
Advance knowledge of cGMP relevant to the pharmaceutical industry; knowledge of the local and international GMP regulations and a strong familiarity with production operations.
Strong knowledge with audit or inspection management.
Demonstrated ability to communicate clearly and professionally both in writing and verbally.
Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional teams. Have proven ability to work well under pressure.
Demonstrated ability to make sound decisions about scheduling, allocation of resources and management of priorities.
Takes responsibility, drives results and achieves expected outcomes.
Strong influencing ability and able to effectively build trust and relationships.
Detail oriented with strong leadership skills, problem solving ability and excellent interpersonal and communication skills; interacts with internal and external stakeholders and management.
Appointment to this position will be on local Singapore salary and benefits package.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.