Senior Quality Associate

CSL Plasma•Waltham, MA

2d•$94,000 - $111,000

About The Position

The Sr. Quality Associate is responsible for m anaging deviations, investigations, CAPAs, product technical complaints and change controls associated with development activities and manufacture of Investigational Medicinal Product within CSL Clinical development portfolio. To do this the GMP Sr. quality associate will has the primary purposes of ensuring compliance with GMP/GSP/GxP by providing front like quality guidance and support across all phases of Technical Product Development. You will also e nsure self-inspections are conducted and followed up in a timely manner and provide quality and compliance support throughout all aspects of technical product. This role reports to: Regional Product Development Quality Lead (APAC/EU) Positions reporting into this role: This role has no direct reports Main Responsibilities and Accountabilities: Participate in IPT Project and associate delivery team meetings, provide quality/compliance leadership, guidance and advice. Manage deviations and OOS investigations and facilitate/attend Deviation Review Board meetings as required. Manage and facilitate the deviation meeting process, manage deviations to closure, including significant and complex deviations, to ensure that information recorded is comprehensive, and remedial actions are appropriate and executed in a timely manner. Facilitate change panel meetings, manage change controls to completion, including significant and complex changes, to ensure changes are appropriate and comply with regulatory requirements. Liaison with Technical departments for quality assurance and compliance related issues. Manage Product Technical Complaints and associated investigations. Review and approve Technical Document Change Requests. Conduct self inspections, provide reports in a timely manner, assess responses and provide quality advice to maintain regulatory compliance and continuous improvement. Provide training in QMS principles as required. Participate in updating of QA Documents as relevant to Technical Development. Provide QA compliance review and approval of relevant product documents. Attend and manage Quality Risk Assessments (QRAs) as required. Educate technical staff in GxP and quality system requirements. Establish and maintain local and global product related Quality Agreements. Education A degree in a relevant biological science, with at least 3 years experience in at least one of: manufacturing under GMP, Regulatory Affairs, Quality Assurance or relevant Process Development Essential Skills, Knowledge and Attributes In-depth understanding of GMP requirements in the pharmaceutical industry and Previous Production, Quality or R&D experience within the Pharmaceutical industry. Sound knowledge of processes for Clinical Trial GMP Manufacture. Understanding of the product development process and environment is desirable. Good interpersonal, negotiation and influencing skills. Ability to relate to and communicate with people of different technical skill backgrounds and at different levels from management to operations within CSL. Good analytical and problem solving skills. Ability to work well independently and to self-motivate. Well developed organisational and time management skills. PC skills (Microsoft Office). Strong oral and written communication skills. Team orientated. Strong customer focus.

Requirements

A degree in a relevant biological science, with at least 3 years experience in at least one of: manufacturing under GMP, Regulatory Affairs, Quality Assurance or relevant Process Development
In-depth understanding of GMP requirements in the pharmaceutical industry and Previous Production, Quality or R&D experience within the Pharmaceutical industry.
Sound knowledge of processes for Clinical Trial GMP Manufacture.
Good interpersonal, negotiation and influencing skills.
Ability to relate to and communicate with people of different technical skill backgrounds and at different levels from management to operations within CSL.
Good analytical and problem solving skills.
Ability to work well independently and to self-motivate.
Well developed organisational and time management skills.
PC skills (Microsoft Office).
Strong oral and written communication skills.
Team orientated.
Strong customer focus.

Nice To Haves

Understanding of the product development process and environment is desirable.

Responsibilities

Participate in IPT Project and associate delivery team meetings, provide quality/compliance leadership, guidance and advice.
Manage deviations and OOS investigations and facilitate/attend Deviation Review Board meetings as required.
Manage and facilitate the deviation meeting process, manage deviations to closure, including significant and complex deviations, to ensure that information recorded is comprehensive and remedial actions are appropriate and executed in a timely manner.
Facilitate change panel meetings, manage change controls to completion, including significant and complex changes, to ensure changes are appropriate and comply with regulatory requirements.
Liaison with Technical departments for quality assurance and compliance related issues.
Manage Product Technical Complaints and associated investigations.
Review and approve Technical Document Change Requests.
Conduct self inspections, provide reports in a timely manner, assess responses and provide quality advice to maintain regulatory compliance and continuous improvement.
Provide training in QMS principles as required.
Participate in updating of QA Documents as relevant to Technical Development.
Provide QA compliance review and approval of relevant product documents.
Attend and manage Quality Risk Assessments (QRAs) as required.
Educate technical staff in GxP and quality system requirements.
Establish and maintain local and global product related Quality Agreements.