- Salary: Undisclosed
- Location: Singapore - West
- Work Type: Permanent / Full Time
- Min. Education Level: Degree
- Field of Study: Not Applicable
- Years of Experience: 7
- Skills: Quality Management
- Responsible for management of all compliance programs and providing Quality oversight of compliance activities in accordance with Roche policies, standards, procedures and Global cGMPs.
- Management and/or participation of inspection related activities such as:
- Regulatory inspections and corporate GMP audits
- Internal inspection program
- Inspection readiness activities
- Supplier management program and
- Emerging regulations and systematic evaluation of new requirements
- Management and maintenance of Quality Agreements.
- Creation and oversight of Quality Compliance Performance metrics.
- Serve as Regulatory liaison by supporting queries from Health Authorities’ and internal business partners.
- Participate in cross-functional project teams and work effectively with multiple disciplines and personalities to support licensure of Singapore Manufacturing Facility.
Technical and Functional
Inspection Management (Health Authorities, self-inspection, internal audits):
- 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.
- 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.