SUMMARY OF
POSITION
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ㆍThe Team Leader of GXP Quality Assurance will report to the VP and Head of Global QA.
This position will be focused on ensuring GXP compliance with regulatory authorities, driving and
implementing the Company’s compliance directives and supporting quality management systems to
ensure compliance and minimize risk in a regulated pharmaceutical environment.
ㆍThe incumbent will conduct and or participate in all GXP QA audit programs which include both
internal and external GXP audits.
ㆍThis position will provide day to day support to the VP and Head of Global Quality in clinical,
Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites for development activities,
and all relevant vendors to support clinical trials including commercial product activities for API.
ㆍThe team leader of GxP Quality Assurance will work with cross functional teams, communicate with
QA consultants (if necessary) and has contact with external auditees, vendors, partners and affiliates.
ㆍThe team leader of GxP Quality Assurance provide support in maintaining internal QMS systems,
oversee commercial and computer systems validation activities |
DUTIES AND
RESPONSIBILITIES |
ㆍProvide/Handle an oversight on a day-to-day activity for GXP activities which includes multiple
clinical studies, clinical/commercial manufacturing, technical transfers, due diligence, product releases,
complaints oversight, and GLP non-clinical studies.
ㆍProvide supervisory support to GXP employees.
ㆍManage, and supervise SKBP Internal Quality Management System (Product Quality Complaints,
Change Controls, Deviations CAPAs, SOPs, Internal Audits, external audits, and appropriate employee
training programs).
ㆍManage SKBP External audit program (including CRO/Vendors/CMOs and other vendors audits)
for initial qualification, re-qualification and for-cause audit.
ㆍProvide support in reviewing and approving CMOs/CROs/ and Vendors Deviation, Investigations,
CAPAs, Quality Agreements, and Change controls
ㆍAssist VP and Head of Quality Assurance with meeting Regulatory requirements, handling regulatory
Inspections and assist in managing Post Marketing Commitments, including Quality Management
Systems reviews, Annual Product Reviews and Annual Reports
ㆍAssist VP and Head of Global QA with Regulatory Submission reviews (IND, NDA, Information
Amendments, Annual Reports (IND/NDA), and other regulatory filings,
ㆍOrganization of all QA documents for Inspection readiness at all times
ㆍReview and Approve CAPAs, Investigations, and Product Complaints as required
ㆍMaintain GxP training program.
ㆍWrite, revise and maintain/manage local/global SOP, Policies, and work instructions for Quality
Assurance.
ㆍReview and approve batch releases for clinical (all programs) and commercial products.
ㆍProvide GCP QA oversight for all clinical studies.
ㆍProvide QA support to IT team for 21 CFR compliance and validation of the software systems.
ㆍActs as Subject Matter Expert / Point of Contact to provide expertise and knowledge to less
experienced auditors, business partners and the core business sector on GxP compliance related issues
ㆍPromote Quality culture for getting things right first time with assurance of data integrity
ㆍProficient in computer software Word, excel, access, power point etc. |
SUPERVISION
EXCERCISED |
ㆍSupervise GxP team members
ㆍProvide day to day support for the entire QA team, become a key contact in QA team
ㆍcommunication with VP of QA and Document Management
ㆍProvide the support in managing the consultant QA as needed |
EDUCATION
PREFERRED |
ㆍBS or MS degree in scientific, health care or related discipline |
WORK
EXPERIENCE |
ㆍ15+ years of pharmaceutical experience
ㆍIntensive GCP, GMP, GLP and safety background
ㆍExperience with both internal and external audits
ㆍStrong knowledge of development policies, procedures and standards (SOPs, QMS)
ㆍAbility to work with global QA teams in developing CSPV/ GCP/GLP QA
ㆍobjectives for audits of investigator sites |
PHYSICAL AND
MENTAL
REQUIREMENTS |
ㆍAbility to multitask
ㆍAdapts to change
ㆍMaintain composure under pressure
ㆍAbility to follow verbal or written instructions and use of effective verbal communications
ㆍAdapts change, adjust change and grasps information quickly
ㆍExamine and observe details
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| OTHER |
ㆍAt least 20% national and international travel required
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