Job description

• Supports the Quality Systems function with responsibilities for the implementation of new electronic systems and quality processes, oversight of internal/External audits, change management, training, documentation, and Quality relevant IT systems

• Makes technical decisions and oversees the process for change control

• Participates on teams to provide highly scientific evaluation of issues intended to mitigate business, product quality and compliance risk

• Implements processes that ensure adherence to global quality requirements

• Maintains awareness of current GMP trends and manufacturing processes and provides input to global procedures and directives

• Supports the management of continuous improvement within the Quality Unit

• Provides support for regulatory agency inspections and requests

• Interacts directly with external and internal customers

• May conduct audits at relevant supplier sites (internal and external)

Qualifications

• Bachelor Degree in (Bio-) Chemistry, Pharmacy, Biotechnology or an equivalent combination of education and experience

• Minimum of 3 years of relevant experience in QA

• General knowledge and experience in biopharmaceutical subject matter areas including: Manufacturing of bulk, intermediates and final containers; Product inspection and labeling; Aseptic processing, Environmental monitoring; Contract manufacturing

• General cGMP experience and knowledge, QA/QC and regulatory compliance (US and other international agencies)

• Ability to make tough decisions under pressure and be able to adapt to changes in organization structure

• Good interpersonal skills

• Skilled in achieving results and managing others to achieve

corporate, site, and departmental objectives

• Ability to interact and gain the support of management

• Serves as a liaison with regulators, internal auditors or external clients

• Ability to effectively manage multiple, complex priorities

• Excellent communication skills, good presentation and influencing skills

• Ability to work cooperatively in teams and peer relationships