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OXB · 1 day ago

Senior Manager, Quality Assurance

Durham, NC

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. They are seeking a Senior Manager, Quality Assurance to lead the Quality Assurance Validation team, ensuring compliance with established quality processes and standards while driving continuous improvement. The role involves guiding the team through complex challenges, overseeing validation documents, and implementing new policies to support quality systems.

BiotechnologyGeneticsTherapeutics

No H1B

Responsibilities

Has in-depth or breadth of expertise in product lifecycle, process validation, analytical methods, computer systems, tech transfers, shipping validation and broad knowledge of related functions developed from considerable work experience

Leads team/workstream through navigating complex problems that have a broad impact on the business and successfully drives solutions to such things as quality systems, audits, inspections, change controls, and validation documents

Proven ability to effectively lead team/workstream with a meaningful impact on critical goals

Accountable for the performance and results of a Quality Validation area or workstream with a broad impact on the organization

Provides guidance, review and approval of internal validation documents including validation plans, requirement documents (URS, FS, CS), protocols, data analysis, and final reports

Drives the implementation of new policies and procedures to support quality systems

Exercises judgment within and outside of defined procedures and practices to determine appropriate action

Sound knowledge and understanding of FDA and foreign requirements and expectations

Works closely with all site functional teams (Manufacturing, Facilities, QC, etc) responsible for protocol development and execution to provide QAV support

QA Approval of change controls and validation documents e.g. Impact Assessment, Risk Assessment, Protocol, Report, and User Requirements

Provides QA support for validation activities including:

Technology Transfer

Process Validation

Analytical instrument qualification, use and maintenance

Computer systems validation

Equipment and Facilities commissioning, qualification, use and maintenance

Cleaning validation

Qualification

Quality AssuranceProcess ValidationTechnology TransferCGMP GuidelinesAnalytical MethodsMicrosoft OfficeRisk Based ApproachesLeadership SkillsCommunication Skills

Required

Bachelors' and/or Masters' degree in Engineering, Biochemistry or related field required

Technical understanding of biopharmaceutical production

A minimum of ten (10) years of experience in the industry, ideally all clinical phases through commercial drug product

Knowledge of cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements relevant for process, cleaning and equipment validation

Knowledgeable of Data Integrity requirements

Leadership skills to lead cross functional teams to ensure project success

Excellent written and verbal communication skills including the ability to communicate, influence and negotiate across the organization

Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project

Ability to travel approximately 5-10% based on project demand