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General Description:

Supports QA investigation activities, ensuring the successful day to day management of: Deviations, root cause

analysis, CAPA’s, effectiveness checks, internal and external customer complaints, and related support activities. Works to support QA Key Performance Indicators (KPIs) such as SOP mandated cycle times, on time closure dates, and QA objectives, whilst adhering to regulatory compliance and achieving business success. Work to support both internal GMP audits and Health Authority audits. Supports QA Manufacturing related tasks as assigned by QA Management.to ensure the efficient and effective day to day running of the QA Manufacturing Team.

Essential Functions of the job:

+ Ensures the development of Manufacturing QA and Compliance SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially.

+ Supports QA manufacturing shop floor activities with resources as needed.

+ Support all QA shop floor and batch systems to ensure compliance with FDA/EU regulations, covering cGMP for commercial medicinal products and clinical material for human use.

+ Significant participation in regulatory and customer inspections/audits.

+ Significant knowledge in GMPs: CFR 210, 211, and 600; knowledgeable in EU Advanced Therapy Medicinal Products (ATMPs).

+ Ensures all activities are performed in accordance with GMPs, SOPs and Health and Safety policies.

+ Maintaining an awareness of new and proposed legislation that impacts the business and communicating any changes to the Senior Management Team.

+ Ensuring that the QA batch release function and Deviation and CAPA processes meet or improve key performance indicators (KPIs).

+ Supervises direct reports, to ensure compliance with business procedures and GMP’s

+ Ensuring appropriate investigation of discrepancies, errors, complaints, failures, or adverse events requiring documented review and action.

+ Undertaking any other duties for any department within the business, which may be requested by the QA Department Head, for which training and/or an explanation has been provided and the scope of work is understood.

Core Competencies, Knowledge, and Skill Requirements

+ Scientific degree (ideally biotechnology, biology, pharmacy, pharmaceutical sciences, chemistry or related scientific field).

+ Minimum of 5+ years of experience in biological quality assurance, preferably with advanced knowledge of large molecule manufacturing in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility required.

+ Minimum of 2-5 years of experience in people management, knowledge of cGMP and Data Integrity Guidance utilized in a manufacturing operations environment.

+ Demonstrable track record and skills/experience gained within a similar position(s), at a similar level.

+ Working knowledge of cGMPs: 21CFR parts 2010 & 211, knowledge of 21CFR600 – Biologics desirable.

+ Wide knowledge of products and processes used in the manufacture of unlicensed medicines (clinical materials, mfd. under and IND or IMP). Knowledge of commercial BLA products.

+ Strong personal leadership skills and experience, ability to lead small teams.

+ Good communicator (written and verbal) and strategic thinker, highly customer focused.

+ Strong analytical and problem-solving ability.

+ Strong project management skills.

+ Hands-on approach, with a ‘can do’ attitude.

+ Ability to prioritize, demonstrating good time management skills.

+ Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.

+ Self-motivated, with the ability to work proactively using own initiative.

+ Committed to learning and development.

+ Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook)

Significant Contacts

+ Interacts with BeOne employees in all departments; CMOs.

Supervisory Responsibilities:

+ Supervises direct reports within the Manufacturing QA and Compliance Team, assists with batch review and release as necessary. QA, Mfg. shop floor QA oversight. Works to ensure that QA Compliance requirements are adequate and meet global standards.

Computer Skills:

+ Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

+ Ability to work on a computer for extended periods of time

Other Qualifications:

Education Required:

Bachelor of Science Degree (or above) in a related scientific discipline

Must be able to work in the US without corporate sponsorship.

Travel:

+ Ability to travel approximately10%; Requires a valid passport.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.