Senior Quality Associate
BioSpace, Waltham, MA, United States
The Sr. Quality Associate is responsible for managing deviations, investigations, CAPAs, product technical complaints and change controls associated with development activities and manufacture of Investigational Medicinal Product within the CSL Clinical development portfolio. The role ensures compliance with GMP/GSP/GxP by providing quality guidance and support across all phases of Technical Product Development. Self‑inspections are conducted and followed up in a timely manner, and quality and compliance support is provided throughout all aspects of technical product.
Reports to:
Regional Product Development Quality Lead (APAC/EU)
Direct reports:
None
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 or attend Deviation Review Board meetings as needed.
Manage and facilitate the deviation meeting process; ensure closure of deviations, including significant and complex deviations, ensuring that information is recorded comprehensively and remedial actions are executed promptly.
Facilitate change panel meetings, manage change controls to completion, including significant and complex changes, ensuring changes are appropriate and comply with regulatory requirements.
Liaise 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 give quality advice to maintain regulatory compliance and continuous improvement.
Provide training in QMS principles as required.
Participate in updating QA Documents 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 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 experience in production, quality or R&D 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 independently and self‑motivate.
Well‑developed organisational and time‑management skills.
Proficiency in Microsoft Office.
Strong oral and written communication skills.
Team‑orientated.
Strong customer focus.
The expected base salary range for this position at hiring is $94,000 - $111,000. Total compensation may include incentive compensation and equity.
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
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Reports to:
Regional Product Development Quality Lead (APAC/EU)
Direct reports:
None
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 or attend Deviation Review Board meetings as needed.
Manage and facilitate the deviation meeting process; ensure closure of deviations, including significant and complex deviations, ensuring that information is recorded comprehensively and remedial actions are executed promptly.
Facilitate change panel meetings, manage change controls to completion, including significant and complex changes, ensuring changes are appropriate and comply with regulatory requirements.
Liaise 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 give quality advice to maintain regulatory compliance and continuous improvement.
Provide training in QMS principles as required.
Participate in updating QA Documents 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 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 experience in production, quality or R&D 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 independently and self‑motivate.
Well‑developed organisational and time‑management skills.
Proficiency in Microsoft Office.
Strong oral and written communication skills.
Team‑orientated.
Strong customer focus.
The expected base salary range for this position at hiring is $94,000 - $111,000. Total compensation may include incentive compensation and equity.
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
#J-18808-Ljbffr