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Sr. Manager, Quality Assurance - 2406184053W
Description
Janssen Pharmaceuticals, a member of Johnson & Johnson Family of Companies, is recruiting for a Sr. Manager, Quality Assurance as a member of our Quality team overseeing small molecule Active Pharmaceutical Ingredients (SM-API) and Med Tech raw material components. This position will be located in Athens, GA.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com.
As Senior QA Manager, you will lead a team of QA professional responsible for the quality oversight and release of material manufactured. This role ensures compliance with regulatory requirements and internal company procedures. Provides Quality support to site projects ensuring that all J&J quality standards and global regulatory requirements are being met.
Under your leadership, you ensure the that the GMP activities of manufacturing, packaging, labeling, storage, testing and release are executed as required by applicable regulations.
Key Responsibilities:
Lead a team of Quality professionals through developing team members in reaching quality, business and personal objectives.
Establish and maintain strong relationships with business partners and global quality partners to ensure alignment of objectives and results.
Strengthen the quality culture in the site supporting departments by providing instructions, guidance and/or training on cGMP requirements.
Review and approve procedures and work instructions.
Ensure that documentation and quality records such as Batch Records, Investigations, CAPAs, Change Controls are timely and properly handled by providing quality, compliance and technical expertise such that the internal and external customer expectations are met.
Ensure that nonconformances with potential impact on patient safety and/or product supply are properly escalated.
Support Quality review meetings governing Quality and Compliance metrics and operational business performance of the Quality Unit.
Identify trends and define actions ensuring continuous improvement of Quality and Compliance performance of the site.
Responsible for the approval of SDLC validation documentation including the approval to release system implementations and/or changes for production use.
Remain current in knowledge and skills towards regulatory and industry trends.
Resolves and manages technical and tactical operational problems.
Management of multiple initiatives daily while being flexible and responsive to shifting priorities when needed.
Qualifications
Education:
Required
A minimum of 8years of experience in an FDA-regulated industry (Pharmaceutical, medical device, Biotech).
Excellent listening skills; promotes and incorporates diverse points of view.
Experience in SAP or other inventory management platforms.
Preferred
Previous people management experience.
Knowledge of ICH Q7 guidelines and ISO 13485.
Drives innovation within functional area, strong collaboration, interdependent partnering and influence skills.
Able to encourage trust and quickly build credibility.
Excellent strategic and big picture thinking ability, complemented by operational and business planning orientation.
Proficiency in skills including, Quality Strategy, Applications and Infrastructure, Data Integrity, Quality Theory, Testing, Quality Management Systems.
Additional professional GxP certifications.
Other:
This position requires to work fully on-site in support of Manufacturing activities at Athens, GA.
Must be willing to work beyond traditional hours to support needs of business partners on a scheduled or emergency basis.
This position may require up to a 10% of domestic travel.
Johnson & Johnson Innovative Medicine Supply Chain is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Primary Location NA-US-Georgia-Athens
Organization Janssen Pharmaceuticals, Inc. (6062)
Travel Yes, 10 % of the Time
Job Function Quality Assurance
Req ID: 2406184053W