Senior Specialist, Quality Assurance

Job Description

The Position

Individual contributor is accountable for ensuring all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and Company policies.

Responsibilities:

• Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, GDP, GQP etc).
• Ensure oversight of an EE involving Quality Agreement, change control, deviation management in order to assure releasing products.
• Leverage an EE to establish robust and effective QMS.
• Ensure quality metrics are complied, analyzed and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
• Support an EE for HA inspection readiness and CAPA implementation to improve processes.
• Collaborate with Technical team and Supply chain to keep stable supply without disruption.
• Support a project with company-wise in a quality perspective.

Required Education, Experience and Skills:

• Education: Minimum four year degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred).
• Minimum of 5 years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
• Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationship
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills
• Communicates in English, both verbally and in writing
• Prior management experience preferred.
• Previous experience participating in regulatory inspections.
• Be conversant with all domestic and foreign regulations and compendia governing plant operations.

【主な業務内容】

国内外の規制要件やオルガノンのポリシー、ガイドラインに基づく、製造委託先など社外パートナー（主に日本国内）の品質保証に関する以下の業務：

• 国内外の規制要件（GMP. GDP, GQP等）やオルガノンのポリシー、ガイドラインに基づく、製造委託先など社外パートナーの管理
• 社外パートナーとの品質に係る取決めの締結とその維持管理、逸脱管理および変更管理
• 社外パートナーでの効果的かつ頑健な品質システムの構築のサポート
• パフォーマンス（KPI）のトラッキングおよび改善促進のための傾向分析や原因分析の常用
• 社外パートナーへの規制当局査察のサポートならびに不備事項への改善サポート
• 技術部門やサプライチェーンと連携した製品供給へのサポート

必須要件

• 生物学、微生物学、薬学、化学、工学またはそれと同等の学位取得者
• 品質保証、品質管理に関する知識と経験
• 日本語および英語によるコミュニケーションスキル
• 人脈形成スキル、ステークホルダーと適切な関係を構築するスキル

好ましい要件

• 管理業務の経験
• 規制当局査察への参加経験
• 国内外の薬事規制、公定書等の知識

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R525686