Quality Assurance Operations Manager- QA GMP/GDP

Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes two offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

Summary: **This is a Hybrid role requiring two office visits per week OR eight office visits per month**

The Manager, Quality Assurance Operations is responsible for Quality Oversight of Clinical QA GMP/GDP operations, Oversight of Contract Manufacturing Organizations, 3PLs and disposition of material. This role includes CMO batch documentation review to ensure our clinical supplies follow current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. 

Essential Functions:

•    Evaluation and disposition of packaged clinical supply materials with the assurance that the materials were produced in conformance with all applicable policies/procedures of our Company and compliance with all governing regulations.

•    Review production and packaging records, shipping temperature data loggers, Certificates of Analysis, Certificates of Compliance and authorize product distribution on behalf of Kyowa Kirin North America (KKNA).

•    Review and approve investigations, temperature excursions, Out of Specification results, deviations and complaints as required.  

•    Liaise with external suppliers - Contract Manufacturing Organizations (DS, DP, Packing, Labs), 3PLs and Kyowa Kirin global locations.

•    Support reviews of IND and CTA applications.

•    Ensure that documents and data comply with Data Integrity regulations and expectations.

•    QA Lead for all Clinical GMP/GDP requirements associated with the manufacture, release and distribution of clinical trial material.  

•    Responsible for the development of Product Specification Files to support the release of clinical trial material.

•    QA Lead on cross regional/functional Clinical Product team meetings. 

•    Supports during regulatory inspections of Kyowa Kirin Facilities and GxP CMOs.

•    Author and review quality related SOPs for KKNA.

•    Develop relationships and establish, update and monitor compliance to Quality Technical Agreements with CMOs, Kyowa Kirin sites and affiliates which are involved in the manufacturing, packaging & distribution operations.

Requirements:

•    Bachelor’s degree in a relevant scientific/technical discipline or equivalent experience in the pharmaceutical industry.

•    Strong knowledge and experience of Biologics and Small Molecule pharmaceutical industry. Minimum of 5 years of experience in the pharmaceutical industry which relates to the responsibilities as stated.

•    Strong knowledge of international cGMP and health authority expectations.

•    Prior experience with batch disposition (release) activities and GMP clinical batch record review of packaging and labeling are a strongly preferred skills necessary for success in this position.

•    Experience of being a product quality lead with the ability to participate and communicate effectively on cross-functional teams, across business unit lines and geographic regions - representing QA on project teams - e.g. QA lead on clinical product team. 

•    Previous experience in one of the following quality control, quality assurance, auditing or regulatory affairs.

•    Ability to evaluate technical information and render judgments on quality risks and regulatory compliance.

•    Strong organizational skills with the ability to participate and communicate effectively on cross-functional teams, across business unit lines and geographic regions.

•    Effective technical, verbal & written communication skills and strong overall interpersonal skills

•    Ability to communicate and manage change effectively across cross functional teams and regions where applicable.

Technical Skills:
Strong computer skills are essential, with a good working knowledge of Microsoft Office Suite as a minimum requirement.  Experience with computerized QMS systems (i.e Veeva, Trackwise etc.)

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center, Suite 600, Princeton, New Jersey 08540 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected]. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at [email protected].

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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