Easter Seals Jobs

General Description:

The job holder is responsible for ensuring the commercial products at CMOs are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. The role has global responsibility and accountability for commercial product quality for global supply. The job holder leads and develops a staff of Quality professionals to ensure the product quality from CMOs as well as closely work with Distribution and Regional Quality team to oversee commercial product on the end to end supply chain. The job location could be in US, EU or China i.e. should be close to where CMOs are based.

The scope of the role will include but not limited to the following,

• Both small molecule and large molecule commercial products

• For DS, DP, FP stages at CMO

• Including partnering products where BeiGene is the MAH for the market

• Managing quality issues and changes at CMOs

Essential Functions of the job:

• Lead Small Molecule and Large Molecule commercial product quality team to ensure the quality management process is in place and executed to ensure the product quality is compliant with regulatory requirements and BeiGene standards.

• Perform batch record review

• Lead batch related deviation handling in investigation and effective CAPA implementation at CMO

• Manage change controls

• Perform batch dispositions

• Perform PIP (Person in Plant)

• Prepare batch related documents e.g. COA

• Manage temperature excursion from storage and transportation.

• Ensure that quality processes meet Health Authorities expectation and continuously improve it by timely capturing related regulation changes

• Advise and support Quality Agreement content, implementation, and updates.

• Obtain quality performance information at CMOs and drive continuous improvement. Provide the performance metrics information to CMO vendor management team and escalate any quality or compliance issue timely to senior management when needed.

• Closely collaborate with the CMO Vendor Management team on vendor performance monitoring and periodic review, support in audits as required

• Will work cross functionally and collaboratively in BeiGene with e.g. Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU.

• Provide quality support on product commercial supply e.g. timely batch release

• Support GCP inspections in IMP manufacturing perspective

• Execute product recalls from commercial supply chain when needed

• Perform other tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelines

Supervisory Responsibilities:

• Responsible for management, development and co-ordination of a medium sized team of direct staff who are based globally

• With strong cross culture leadership

• Accountable for financial control and for the management of related budgets such as headcount related and travel.

• Ensures sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency.

• Build talent pipeline by inspiring and encouraging team members and create a great place to work for their personal development and career success.

Core Competencies, Knowledge, and Skill Requirements

• Bachelor of Science degree or above, in a related scientific discipline/technical filed such as Pharmacy, Biology, Chemistry or Engineering

• Minimum 12 years pharmaceutical or biotechnology industry experience

• In-depth GMP experience in a quality and manufacturing function

• Prior experience in commercial GMP batch release

• In-depth knowledge of Quality principles, concepts, industry practices and standards

• Working Knowledge and experience with US, EU, ICH and/or China GMP regulations as well as international regulations

• Excellent interpersonal skills, including communication, negotiations, facilitations

• Experience in working in a cross-functional and international environment

• Good presentation skills

• Ability to work independently

• Spoken/Written fluency in English required

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Other Qualifications: N/A

Travel:

• May travel regionally and intercontinentally estimated up to 30%

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.