BioSpace, Inc.
Senior Manager, Quality Document Control
BioSpace, Inc., Emeryville, California, United States, 94608
Job Details
Attention recruitment agencies:
All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.
Company Differentiators:
• Fully integrated clinical-phase company with internal manufacturing• Demonstrated ability to move rapidly from idea to IND• Five candidate products in the clinic and two declared pre-clinical programs• Robust technology and IP foundation, including our TVE and manufacturing platforms• Initial product safety and efficacy data substantiates the value of our platforms• Opportunities to expand to other indications and modalities within genetic medicine
The Senior Manager, Quality Document Control, will manage 4DMT's Quality Document Control Program. Reporting to the Sr. Director of Quality Systems and GCP Compliance, the Senior Manager, Quality Document Control, will be responsible for 4DMT's Quality Document Control Program, which is designed and executed in an efficient, compliant, and inspection-ready manner.
This role can be in-person or hybrid. If Hybrid, the role will require regularly scheduled time on-site at 4DMT's Emeryville office at least weekly.
RESPONSIBILITIES:
Quality Document Control Operations / Document Management - 70%Perform document control review of 4DMT Policies, SOPs, and Work Instructions and exercise judgment to provide suggestions to align document content and format with 4DMT procedural requirements, standards, templates, and best practicesPerform document control consistency/quality/formatting checks of all new / revised quality-controlled documentsCoordinate the review, finalization, and obsoletion of select 4DMT policies and procedures with stakeholdersEnsure compliance with Quality Controlled Document procedures through close collaboration with document authors, owners, and reviewersCoordinate with Quality Training to ensure training requirements are established for new and revised procedures ahead of their releaseProvide support during audits and inspectionsEnsure that quality-controlled hard-copy/paper files are managed and maintained, including via maintenance of an index, check-in/out procedures, and general securityEnsure that controlled document-related compliance reporting and inspection readiness support is provided to stakeholdersSupport archival of controlled documents in the EDMS as neededOther duties as assigned: nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time4DMT's Quality Document Control System / Process Owner - 30%
Define/update policies and procedures related to 4DMT's Quality Document Control ProgramWork with functional leaders across the business to ensure GXP-controlled document requirements are defined appropriately and implemented within the electronic document management system (EDMS).Provide direction/guidance on EDMS configuration and related processes to IT EDMS system administratorsEnsure the EDMS is configured and administered to manage quality-controlled documents in an efficient, compliant, and inspection-ready manner.Work with interdepartmental subject matter experts at all levels of the organization to plan, develop, and coordinate execution of GXP Controlled Document programs/initiativesLead execution of User Acceptance Testing of EDMS features related to quality-controlled documentsParticipate in cross-functional project teams to refine controlled document processesQUALIFICATIONS:
Education:
Bachelors Degree a minimumExperience:
8+ years of experience in biotech/pharmaceutical industry, including in a position leading a controlled document-related program/process4+ years of managerial experienceExpert knowledge of GxP concepts and guidelines as they relate to controlled document requirementsAdvanced business knowledge of Clinical Research, Development, and Manufacturing in the pharmaceutical industryDemonstrated ability to manage multiple, highly complex projects concurrentlyPrior experience in monitoring adherence to document control programsDemonstrated ability to influence and negotiate effectively and implement large-scale changeExperience with EDMS platforms used within Life SciencesSubject matter expert of ACE or VeevaSkills:
Expert Knowledge of MS Word Document formatting and processingExcellent written and verbal communication skillsStrong organizational skillsProficiency in Microsoft Office (Outlook, OneNote, Excel, Word, PowerPoint), Adobe Acrobat, and survey tools.Knowledge of GCPs, GLPs and GMPs
Base salary compensation range: $155,000 - $190,000
Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
Attention recruitment agencies:
All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.
Company Differentiators:
• Fully integrated clinical-phase company with internal manufacturing• Demonstrated ability to move rapidly from idea to IND• Five candidate products in the clinic and two declared pre-clinical programs• Robust technology and IP foundation, including our TVE and manufacturing platforms• Initial product safety and efficacy data substantiates the value of our platforms• Opportunities to expand to other indications and modalities within genetic medicine
The Senior Manager, Quality Document Control, will manage 4DMT's Quality Document Control Program. Reporting to the Sr. Director of Quality Systems and GCP Compliance, the Senior Manager, Quality Document Control, will be responsible for 4DMT's Quality Document Control Program, which is designed and executed in an efficient, compliant, and inspection-ready manner.
This role can be in-person or hybrid. If Hybrid, the role will require regularly scheduled time on-site at 4DMT's Emeryville office at least weekly.
RESPONSIBILITIES:
Quality Document Control Operations / Document Management - 70%Perform document control review of 4DMT Policies, SOPs, and Work Instructions and exercise judgment to provide suggestions to align document content and format with 4DMT procedural requirements, standards, templates, and best practicesPerform document control consistency/quality/formatting checks of all new / revised quality-controlled documentsCoordinate the review, finalization, and obsoletion of select 4DMT policies and procedures with stakeholdersEnsure compliance with Quality Controlled Document procedures through close collaboration with document authors, owners, and reviewersCoordinate with Quality Training to ensure training requirements are established for new and revised procedures ahead of their releaseProvide support during audits and inspectionsEnsure that quality-controlled hard-copy/paper files are managed and maintained, including via maintenance of an index, check-in/out procedures, and general securityEnsure that controlled document-related compliance reporting and inspection readiness support is provided to stakeholdersSupport archival of controlled documents in the EDMS as neededOther duties as assigned: nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time4DMT's Quality Document Control System / Process Owner - 30%
Define/update policies and procedures related to 4DMT's Quality Document Control ProgramWork with functional leaders across the business to ensure GXP-controlled document requirements are defined appropriately and implemented within the electronic document management system (EDMS).Provide direction/guidance on EDMS configuration and related processes to IT EDMS system administratorsEnsure the EDMS is configured and administered to manage quality-controlled documents in an efficient, compliant, and inspection-ready manner.Work with interdepartmental subject matter experts at all levels of the organization to plan, develop, and coordinate execution of GXP Controlled Document programs/initiativesLead execution of User Acceptance Testing of EDMS features related to quality-controlled documentsParticipate in cross-functional project teams to refine controlled document processesQUALIFICATIONS:
Education:
Bachelors Degree a minimumExperience:
8+ years of experience in biotech/pharmaceutical industry, including in a position leading a controlled document-related program/process4+ years of managerial experienceExpert knowledge of GxP concepts and guidelines as they relate to controlled document requirementsAdvanced business knowledge of Clinical Research, Development, and Manufacturing in the pharmaceutical industryDemonstrated ability to manage multiple, highly complex projects concurrentlyPrior experience in monitoring adherence to document control programsDemonstrated ability to influence and negotiate effectively and implement large-scale changeExperience with EDMS platforms used within Life SciencesSubject matter expert of ACE or VeevaSkills:
Expert Knowledge of MS Word Document formatting and processingExcellent written and verbal communication skillsStrong organizational skillsProficiency in Microsoft Office (Outlook, OneNote, Excel, Word, PowerPoint), Adobe Acrobat, and survey tools.Knowledge of GCPs, GLPs and GMPs
Base salary compensation range: $155,000 - $190,000
Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities