[SUMMARY OF POSITION]
1.    The Team Leader of GMP Quality Assurance will report to the VP and Head of Global QA. This position will be focused on ensuring GMP 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 for small modules and radio pharmaceuticals
2.    The incumbent will conduct and or participate in all GMP QA audit programs which include both internal and external GMP audits.
3.    This position will provide day to day support to the VP and Head of Global Quality on API Manufacturing to manage CMOs, vendors, and laboratories for development, and commercial products.
4.    The team leader of GMP Quality Assurance will work with cross functional teams, communicate with QA consultants (if necessary) and has contact with external auditees, vendors, partners and affiliates.
5.    The team leader of GMP Quality Assurance provide support in maintaining internal QMS systems, and computer systems validation activities as applicable including R&D activities

[DUTIES AND RESPONSIBILITIES]
1.    Provide/Handle an oversight on a day-to-day activity for GMP API and Intermediates activities which includes multiple clinical studies, clinical/commercial manufacturing, technical transfers, due diligence, product releases, complaints oversight, and GLP non-clinical studies.
2.    Provide supervisory support to GMP employees.
3.    Manage, and supervise SKBP Internal Quality Management System (Product Quality Complaints, Change Controls, Deviations CAPAs, SOPs, Internal Audits, external audits, and appropriate employee training programs).
4.    Manage SKBP External audit program (including CMO/and or other vendors audits) for initial qualification, re-qualification and for-cause audit.
5.    Provide support in reviewing and approving CMOs/ and Vendors Deviation, Investigations, CAPAs, Quality Agreements, and Change controls
6.    Assist 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
7.    Assist VP and Head of Global QA with Regulatory Submission reviews (IND, NDA, Information Amendments, Annual Reports (IND/NDA), and other regulatory filings,
8.    Organization of all QA documents for Inspection readiness at all times
9.    Review and Approve CAPAs, Investigations, and Product Complaints as required
10.    Maintain GMP/GXP training program.
11.    Write, revise and maintain/manage local/global SOP, Policies, and work instructions for Quality Assurance.
12.    Review and approve batch releases for clinical (all programs) and commercial products.
13.    Provide QA support to IT team for 21 CFR compliance and validation of the software systems.
14.    Acts as Subject Matter Expert / Point of Contact to provide expertise and knowledge to less
experienced auditors, business partners and the core business sector on GMP compliance related issues
15.    Promote Quality culture for getting things right first time with assurance of data integrity
16.    Proficient in computer software Word, excel, access, power point etc.

[SUPERVISION EXCERCISED]
1.    Supervise GMP team members
2.    Provide day to day support for the entire QA team, become a key contact in QA team
3.    communication with VP of QA and Document Management
4.    Provide the support in managing the consultant QA as needed

[EDUCATION PREFERRED]
- BS or MS degree in scientific, health care or related discipline

[WORK EXPERIENCE]    
1.    15+ years of pharmaceutical experience
2.    Intensive GMP/GLP and CSV experience
3.    Experience with both internal and external audits
4.    Strong knowledge of development policies, procedures and standards (SOPs, QMS)
5.    Ability to work with global QA teams in developing processes

[PHYSICAL AND MENTAL REQUIREMENTS]   
1.    Ability to multitask
2.    Adapts to change
3.    Maintain composure under pressure
4.    Ability to follow verbal or written instructions and use of effective verbal communications
5.    Adapts change, adjust change and grasps information quickly
6.    Examine and observe details

[OTHER]
- At least 20% national and international travel required

[전형 일정]
- 서류 접수 : 10/02~10/20
- 필기 및 면접 전형 : 상세 일정 개별 안내

[기타 사항]
- 국가 보훈 대상자 및 장애인은 관련법에 의거 우대합니다.
- 석,박사 학위 소지자의 경우 학사를 포함한 전체 학력 정보를 기입해 주시기 바랍니다.
- 써치펌과 SK Careers 포털 중복 지원은 불가능 합니다.
- 당사 채용 공고 간 중복 지원은 불가능 합니다.
- 각 전형 일정은 상황에 따라 조정될 수 있습니다.

[근무지]
- 경기도 판교(2025년 10월~11월 사옥 송도 이전 계획)