Karen Dosanjh, CIPM(916) 983-9333

(209) 712-4889

Education

University of California, Davis

B.S., Biochemistry

H 5R1

Career Profile

20 years of successful Blood Bank/Medical Device/Biologics and Compliance/Quality experience.

Expertise in providing regulatory and quality oversight in global projects.

Experienced in Quality Integration during organizational merger/acquisition process.

Knowledgeable in privacy program administration and privacy program lifecycles (CIPM).

Career built in wide-ranging facets of biologics manufacturing, healthcare, and quality assurance.

Adept in organization-wide team leadership.

Strong evaluative, assessment and interpretive capacity in providing advisement to senior management.

Skilled in planning, budgeting, quality and regulatory affairs.

Track record in training, mentoring and employee development.

Well-organized multi-tasker with strong detail orientation.

Proficient in aligning multiple projects with organizational objectives, prioritizing, and meeting timelines.

Professional Experience

BloodSource/BloodSystems, Sacramento, CA2008-Present

Director, Compliance/Quality Assurance

  • Maintain current knowledge of QA & Regulatory standards to ensure compliance to internal policies and procedures, regulations, standards, and policies of FDA, AABB, State of CA, CLIA, HIPAA, OSHA, and EU.
  • Direct and oversee all quality operations of BloodSource Compliance/QA department to ensure centralized functions, as well as all regulated departments, meet the requirements of applicable regulatory and accreditation agencies.
  • Work with HIPAA Privacy Officer for procedural review/content, routine monitoring for potential violations, deviation management review of potential HIPAA violations.
  • Serve as Quality consultant to the IT group, providing guidance for software initiatives and electronic solutions implementation on a company-wide global scale. Provide guidance and support in the selection process of external software solutions, internal software/programming design and development, validation protocol development and review, regulatory review cycles, and federal MDDS requirements.
  • Direct the Deviation Management and Product Recall programs to ensure compliance to regulatory and contractual requirements. Perform risk assessment, product quality review (NCPE/MRB) and provide quality driven directives for all questionable and quarantined products under potential recall.
  • Direct the internal auditing and assessment program; act as a subject matter expert for regulatory information and interpretation, and perform assessments of procedures and practices. Perform mock FDA and mock EU inspections in preparation for third party audits.
  • Oversee 10-15 external regulatory inspections annually. Overseecoordination of external regulatory inspections and work with QA Lead Assessor to prepare inspection responses and submit Pre-Inspection Site Master Files for submission to plasma fractionators/regulatory EU agencies.
  • Review and approve process and computer validation plans and results. Provide QA and regulatory guidance in planning meetings for upcoming initiatives and implementations.
  • Maintain global and corporate procedures and document control, including Quality Plan, corporate documents, HIPAA procedures, and QA departmental procedures.
  • Recommend, initiate, and implement compliance and regulatory policies. Provide direction for compliance/regulatory/quality assurance efforts, including product quality evaluation. Ensure Proficiency Testing program is fully inclusive of all laboratory testing within BloodSource.
  • Ensure existing BloodSource licenses are maintained and new site licensing/registration needs are met; ensure required updates and certificate renewals are submitted in a timely manner.
  • Direct and coordinate regulatory and quality efforts among the medical and operational departments.
  • Direct the Biohazard Exposure Program to ensure compliance to IIPP and applicable regulations.
  • Prepare annual department budget and monitor expenses monthly.

Karen Dosanjh

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Senior Manager, Compliance/Quality Assurance2006-2008

  • Provided technical, regulatory and managerial guidance to the QA Managers and Assistant QA Managers; directed assignments, workload, and workflow to maximize turn-around and staff performance.
  • Provided technical, regulatory and general quality assurance information to BloodSource departments regarding regulatory compliance and interpretation of regulations and standards. Offered recommendations to improve efficiencies and minimize errors. Prepared and presented quality& regulatory training.
  • Directed the Deviation Management and Product Recall programs; monitored, collected, analyzed, trended and reported data.
  • Directed the preparation and submission of FDA Biological Product Deviation Reports.
  • Performed QA review of process and computer validation plans and results.
  • Performed QA review and approval of SOP and forms, as well as contracts.
  • Performed risk assessment and quality assurance evaluation for product quality and consignment issues.
  • Coordinated and ensured regulatory compliance for QA program per Quality Systems, regulations, and SOP.
  • Conducted internal assessments and QA audits of BloodSource Quality Systems and critical control points.

Manager, Compliance/Quality Assurance2002-2006

  • Performed QA data collection, product recalls, customer notification, tracking and trending, report generation, facility licensing, and facility registration.
  • Monitored the Donor and Staff confidential hotline for the Product Recall program. Initiated Product Recall process and performed Lookback.
  • Performed QA review of the following: Deviation Management, departmental and manufacturing SOPs and forms, validation plan and results, FDA Biological Product Deviation Reports, assessments, applicable regulations review for impact and gap analysis, and contracts.
  • Presented quality and regulatory training topics to BloodSource staff, as well as at outside educational programs including AABB and CBBS.
  • Provided quality directives and assisted with root cause analysis investigations; monitored continuous quality improvement.
  • Performed QA system audits and provided regulatory consultation & recommendations to BloodSource staff for overall process improvement.

Earlier Background

Chiron Corp., Emeryville, CA1997-2002

QA/Compliance Specialist

  • Created, implemented, and supported production tracking and trending systems that assisted in evaluation and monitoring of production quality. Ensured conformance to in-house specifications, Quality Systems requirements (21CFR 210, 211, 820). Performed lot release of all RIBA product lines. Reviewed and evaluated manufacturing batch records and QA/QC documents to ensure cGMP compliance, accuracy, completeness, and accountability. Reviewed controlled document changes to ensure compliance and logical soundness. Prepared new procedures for ISO 9000/9001 certification. Prepared lot protocols for FDA surveillance submission, compiled supporting data for surveillance submission requests to the FDA. Assisted in the identification, tracking and trending of, and investigations of deviations in manufacturing process from established standards based on FDA requirements. Prepared customer complaint investigations. Trained staff on technical/scientific aspects of manufacturing processes and test assays/methods and provided work directions to workers.

Liquid Sugars, Inc., Emeryville, CA1996-1997

Quality Control Analyst

  • Investigated the exact constituent content in company and competitor liquid sugar products through the use of HPLC. Performed microbial load testing of specific product lines for bacterial growth and contamination. Analyzed oil shipments. Confirmed quality and consistency of products through release testing. Data entry and trending of test results. Filled customer requests for product samples. Overall laboratory maintenance and safety.

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Calypte Biomedical Co., Berkeley, CA1996

Manufacturing Technician I

  • Followed SOPs to perform manufacturing processes in cell growth, infection, and antigen purification. Conducted assessments to verify manufacturing documentation was accurate, complete, and met cGMP requirements. Maintained records and procedures in accordance with cGMP. Performed multiple QC qualifications and validations of antigen purification process.

Publications

Transfusion, Abstract Supplement, Vol. 49, No. 3S, September 2009 – AP135 Laboratory Relocation – A Quality Perspective

Certifications

IAPP Certified Information Privacy Manager (CIPM)

Yellow Belt in Lean Six Sigma

Certified AABB Assessor

Volunteerism

American Association of Blood Banks Assessor2014

  • Completed volunteer professional training in auditing techniques, quality programs and operations, and competitive legal and ethical issues associated with assessments. Performed an out of state peer review assessment for Donor Center CLIA deemed status and accreditation.

3Strands Global2015

  • Not for profit organization developed locally in the Sacramento region to combat human trafficking through sustainable employment, education, and engagement initiatives by empowering a global community.