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Dalia M. C. Email & Phone Number
Associate Director, Quality Systems
at
Cytokinetics
1 work email found
@huyabio.com
2 phones found area 619
LinkedIn matched
✓ Verified May 2026
4 data sources
Profile completeness 100%
Current company
Role
Associate Director, Quality Systems
Location
United States, United States, United States
Who is Dalia M. C.? Overview
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Quick answer
Dalia M. C. is listed as Associate Director, Quality Systems at Cytokinetics, based in United States, United States, United States. AeroLeads shows a work email signal at huyabio.com, phone signal with area code 619, and a matched LinkedIn profile for Dalia M. C..
Dalia M. C. previously worked as Quality Consultant at Consulting and Associate Director Quality Systems & Compliance at Nuvalent, Inc.. Dalia M. C. holds Ms, Organizational Leadership from National University.
Company email context
Email format at Cytokinetics
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*@huyabio.com
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AeroLeads found 1 current-domain work email signal for Dalia M. C.. Compare company email patterns before reaching out.
Profile bio
About Dalia M. C.
Quality Systems Professional with 19 years of experience in quality systems and assurance in various sectors of the life sciences industry, including pharmaceutical, medical device, biotech, and nutraceutical.My core competencies include developing and maintaining quality management systems, ensuring compliance with FDA and EMA regulations, implementing and validating electronic quality management systems, training and supporting staff, managing vendor relationships, and conducting audits, CAPAs, change controls, and investigations. Extensive knowledge and skills in using EQMS platforms such as EDMS, Veeva RIM, QualityDocs, Training, Veeva QMS, and DocuSign. I am passionate about enhancing the quality and performance of the products and processes that impact the lives and health of millions of people.Key Areas of Expertise:ICH Q7, Q8, Q9, Q10, 21 CFR Part 4, 11, 111, 210, 211, 820, cGMP Standards | Product Portfolio Management | Quality Compliance Management Systems | Quality Events | Internal Audit | Supplier Quality | cGXP Compliance | Contract Negotiations | Records Management | KPIs and Standard Operating Procedures | Business Optimization Strategies/Operational Excellence | Process Development and Execution | IT Quality | Data Integrity | Continuous Process Improvement | Startup Expertise | Team Leadership | Decision Making | Risk Assessments | Coaching and Training | Regulatory Compliance | External Audit
Listed skills include Quality Assurance, Gmp, Fda, Change Control, and 33 others.
Current workplace
Dalia M. C.'s current company
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13 roles · 18 years
Dalia M. C. work experience
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Quality Consultant
Current
Consulting
2024 - Present
~2 yrs 4 mos
Associate Director Quality Systems & Compliance
- Clinical-stage biopharmaceutical company focused on targeted cancer therapies. Oversaw all GXP computerized system activities implementation projects and ensures compliance with regulatory requirements.
- Built and directed team of four (document control, validation support, training administrators) as head for Quality Systems. Built SOPs, training modules, processes, and policies around Quality Systems.
- Led teams through validation process on special project, which led to faster rollout time. Directed team to document control to optimize a process.
- Directed electronic systems project implementation and led companywide training, rollout, SOPs, etc.
- Collaborated with internal departments in selection of GXP Computerized Systems workflows and supported clinical GXP Systems Validation and Implementation, IRT and ePRO implementations.
- Oversaw GxP Systems Quality Agreement development and execution as part of literature review.
2022 - 2024
~2 yrs
Associate Director Quality Assurance
- EDMS Implementation, EQMS Training Validation, system owner/admin, maintenance, system upgrades, and providing daily support to staff
- EQMS Vendor Management Module Validation and Implementation
- System Owner/Admin: provide company wide support, admin responsibilities, training curriculum, andmonitoring of companywide training
- Veeva RIM Implementation: Configuration, Validation, and Data Migration
- Veeva Vault: QualityDocs and Vault QMS implementation
- DocuSign validation, implementation, and training on Part 11 eSignatures Compliant Module companywide
Jan 2021 - Jun 2022
Senior Quality Assurance Manager
2020 - 2021
~1 yr
Qa/Qc Manager
- Facilitated and managed relocation to new facility. Planned and carried out all necessary requirements/permits/registrations for Quality Control Laboratory, R&D Laboratory, and Production/Manufacturing
- Successfully obtained and maintained 2 independent cGMP facility certifications in compliance with 21 CFR Part 111
- Oversee department operations for Quality Assurance/Quality Control with 8 employees
- Oversee validation activities for processes, methods, and equipment. Review and approval validationprotocols
- Review and improve QMS and current processes and procedures
- Manage, investigate and process Product Complaints and Adverse Events
2015 - May 2020
Sr. Quality Systems Specialist
- Management of vendors/CMOs/suppliers/service providers including qualification and maintenance
- Perform GXP external audits to qualify contract service providers and suppliers of raw material/services
- Audit and qualify Contract Manufacturing Organizations
- Perform investigations related to Deviations and CAPA programs
- Participate in the development, implementation, maintenance and continuous improvement of thecompany’s Quality Management System
- Certified Internal Auditor
Sep 2013 - Nov 2015
Quality Assurance Compliance & Manufacturing Support
- QA Manufacturing Compliance and Support
- Supervise Manufacturing Operations
- Initiate and investigate Manufacturing Deviations, CAPAs, and OOS/OOT
- On the job Compliance Training and cGMP training system owner
- GDP staff trainer
- Management of QA holds on equipment and facilities
Mar 2013 - Oct 2013
Quality Assurance
- Performed internal and external quality audits as well as managed supplier/vendor qualification program
- Established and maintained a GMP Training System
- Receive, initiate and investigate Product Complaints, CAPAs, Deviations
- Review and approve Batch Records, Master Batch Records, Calibration Certificates
- Review and approve QC Data, Stability, and SOPs
- Participate in FDA and ISO audits and generate Audit Reports
Apr 2012 - Mar 2013
Quality Assurance Lead
- Support quality systems such as customer complaint investigations, Non-Conforming Events, deviations, CAPA, and change control
- Preparation and presentation of Quality Council Monthly Meetings
- Quality Assurance oversight in Manufacturing. Lead in Quality Assurance Inspections during Manufacturing processes. Issue and reconcile labeling.
- Equipment calibration and validation
- Perform internal and external Quality Audits. Prepare audit reports and corrective action plans
- Inspect and approve rooms, lines and equipment prior to use by manufacturing
2011 - 2012
~1 yr
Qa Change Control Lead
Jan 2010 - Aug 2011
Sr. Quality Specialist
- Managed laboratory personnel and ensured work completeness.
- Developed and implemented GLP programs and laboratory SOPs for lab technicians.
- Raw Materials S.M.E. (Subject Matter Expert). Analyzed and managed all raw materials testing and data.
- Created, analyzed and maintained department metrics on a weekly and monthly basis.
- Managed laboratory budget. Responsible for maintaining and ordering lab supplies.
- Performed lab testing on products from manufacturing and production and approved for releasing. Review, prepare and approved Certificate of Analysis (CoA).
2008 - 2010
~2 yrs
Jan 2005 - Aug 2008
2 education records
Dalia M. C. education
Ms, Organizational Leadership
National University
Bs, Biology/Biological Sciences, General
San Diego State University
FAQ
Frequently asked questions about Dalia M. C.
Quick answers generated from the profile data available on this page.
What company does Dalia M. C. work for?
Dalia M. C. works for Cytokinetics.
What is Dalia M. C.'s role at Cytokinetics?
Dalia M. C. is listed as Associate Director, Quality Systems at Cytokinetics.
What is Dalia M. C.'s email address?
AeroLeads has found 1 work email signal at @huyabio.com for Dalia M. C. at Cytokinetics.
What is Dalia M. C.'s phone number?
AeroLeads has found 2 phone signal(s) with area code 619 for Dalia M. C. at Cytokinetics.
Where is Dalia M. C. based?
Dalia M. C. is based in United States, United States, United States while working with Cytokinetics.
What companies has Dalia M. C. worked for?
Dalia M. C. has worked for Cytokinetics, Consulting, Nuvalent, Inc., Huyabio International, and Cv Sciences.
How can I contact Dalia M. C.?
You can use AeroLeads to view verified contact signals for Dalia M. C. at Cytokinetics, including work email, phone, and LinkedIn data when available.
What schools did Dalia M. C. attend?
Dalia M. C. holds Ms, Organizational Leadership from National University.
What skills is Dalia M. C. known for?
Dalia M. C. is listed with skills including Quality Assurance, Gmp, Fda, Change Control, Capa, Biotechnology, Validation, and Sop.
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