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Syed Yar-Khan

Vice President, Quality @ Baxalta

Vice President of Manufacturing at Takeda

Los Angeles, California

Ranked #1,233 out of 24,660 for Vice President, Quality in California

Section title

Syed Yar-Khan's Work Experience

Baxalta

Vice President, Quality

August 2014 to Present

Zurich, Switzerland

Baxter International Inc.

Senior Director, Quality (QMR)

November 2009 to August 2014

Los Angeles, California

Baxter International Inc.

Director, Quality Assurance

January 2005 to November 2009

Thousand Oaks, CA

Syed Yar-Khan's Education

IMD Business School

Executive MBA Business Administration and Management General

2015 to 2016

University of California, Berkeley

Bachelor of Science Chemical Engineering

1993 to 1996

Syed Yar-Khan's Professional Skills Radar Chart

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Syed Yar-Khan's Estimated Salary Range

About Syed Yar-Khan's Current Company

Baxalta

- Responsible for quality oversight of multiple manufacturing facilities within Europe and the U.S. to include Vienna (Austria), Lessines (Belgium), Rieti/Pisa (Italy), Los Angeles (CA) and Covington (GA). - Responsible for working with site quality heads to set compliance culture, strategy and vision to ensure safe and effective manufacturing of plasma based therapeutics. - Responsible for assisting...

Frequently Asked Questions about Syed Yar-Khan

What company does Syed Yar-Khan work for?

Syed Yar-Khan works for Baxalta


What is Syed Yar-Khan's role at Baxalta?

Syed Yar-Khan is Vice President, Quality


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What is Syed Yar-Khan's Phone Number?

Syed Yar-Khan's phone (213) ***-*275


Who are Syed Yar-Khan's colleagues?

Syed Yar-Khan's colleagues are Karin Graefe, Jana Scalisi, Mercedes Echauri, Alkisti Rouvas, Hester Visser, Subnam Kapadia, Jonathan Menard, Kitti Brady, Yiyuan Ding, and Larry Doris


About Syed Yar-Khan

馃摉 Summary

Leader with over 17 years pharma/biotech experience managing operations in mature fast-paced and start-up manufacturing environments with the ability to implement efficient systems, building and leading an effective organization and providing purpose driven results. Management Summary: Organizational Development, International Business Experience, Strategic Planning Process & Change Management, Budgeting & Resource Management, Multi-Project Management Skills, Strong Leadership and Motivational Skills, Setting Clear Direction and Prioritization of Goals, Talent Management & Team Building Technical Summary: Quality Assurance, Quality Systems, Quality Control, Regulatory Inspection Management, Compliance, Auditing, Manufacturing Processes (Biotechnology, Cell Culture, Purification, Aseptic Filling, Plasma Fractionation)Vice President, Quality @ - Responsible for quality oversight of multiple manufacturing facilities within Europe and the U.S. to include Vienna (Austria), Lessines (Belgium), Rieti/Pisa (Italy), Los Angeles (CA) and Covington (GA). - Responsible for working with site quality heads to set compliance culture, strategy and vision to ensure safe and effective manufacturing of plasma based therapeutics. - Responsible for assisting and supporting on-site regulatory inspections with strong center led Division support. - Responsible for 5 direct reports (site quality heads) and >1000 indirect reports. From August 2014 to Present (1 year 3 months) Zurich, SwitzerlandSenior Director, Quality (QMR) @ Site Quality Head for one of the world鈥檚 largest manufacturing locations of plasma based therapies (4.4M liters plasma annually & 1800 employees); manufacturing immune globulins for treatment of immune deficiencies and Factor VIII for treatment of Hemophilia. Responsible for both Los Angeles, CA and Van Nuys, CA facilities for Quality Assurance, Quality Control, and Quality Systems. Achievements - Prepared, managed and led the site through challenging FDA CBER Team Biologics inspections in 2010 and 2012; both inspections were closed out satisfactorily by FDA with no further action. Managed succesful foreign inspections from Europe, Japan, China, Brazil, Mexico and other emerging markets. - Member of Fit for Growth Steering Committee to realign Division and Facility responsibilities to be more center-led, to standardize organizational structure, and to apply efficiencies to common site based activities and processes between 12 manufacturing sites. - Improved overall compliance profile with strategic changes to improve manufacturing operations and capital investment into facility infrastructure, equipment and processes; support large capital projects for compliance improvements (i.e., new Hemofil-M/Albumin Building, Fractionation Upgrade) - Implemented site wide quality systems/e-solutions for Corrective and Preventive Action (CAPA) and Change Control utilizing Trackwise; led to an increase in on-time closure of investigations from 35% to 75% - Utilized Value Stream Management tools to improve product release from 30% to 90%; also improved Raw Material Release cycle times from 40% to 75% - Built and developed the Extended Quality Leadership Team (30-35 members) to ensure improved succession planning and hiring standards to support future growth and expansion within BioScience From November 2009 to August 2014 (4 years 10 months) Los Angeles, CaliforniaDirector, Quality Assurance @ Directed highly effective quality assurance organization built on a foundation of continuous improvement at manufacturing site utilizing biotechnology processes to manufacture Recombinant therapies for treatment of Hemophilia. Achievements - Obtained FDA licensure for new Isolator Filling Line ($10M) and change of facility status from single product to multi product. - Improved drug substance release cycles from 70% to 95% and drug product release cycle times from 52% to 95%. Presented as best demonstrated practice in BioScience 2006 Leadership Conference. - Completed Lean Instructor, Yellow Belt and Green Belt Training to improve quality systems performance. - Strengthened Quality Assurance organization to attract, retain and develop talent based on QLP fundamentals. - Optimized all quality systems within the facility by developing personnel and applying DMAIC and Lean Methodology to quality systems. All quality systems (CAPA, Supplier Quality, Documentation Control, Exception Management and Change Control) within the facility transitioned from paper based systems to e-solutions. - Member of the Senior Leadership Team (SLT) and ADVATE and RECOMBINATE Product Strategy Teams (PSTs). Also served as Recombinate Product Owner. - Management of a team of 5 direct reports (Senior Managers), 50 indirect reports and a budget of $4M. From January 2005 to November 2009 (4 years 11 months) Thousand Oaks, CASenior Quality Manager @ Establish, implement and maintain reliable methods of problem detection and prevention in order to reduce and prevent process failures and meet all internal and external customer requirements. Responsible for Non-Conformity, CAPA, and Change Control Systems. Achievements 路 Designed and implemented effective Non-Conformity System leading to a 40% annual reduction for non-conformities and reducing average closure time from 60 to 20 days while strengthening investigation standards. 路 Assisted in implementation of Lean Change Control System to substantially reduce cycle time. 路 Key team member in optimizing structure of the Quality Organization in order to improve performance and overall business alignment. 路 Managed and coordinated FDA inspection leading to no observations and expedited approval. Performed mock FDA PAI Corporate Audits of multiple European facilities. 路 Managed and developed staff of 9 individuals in Exception Management and Change Control. From March 2003 to January 2005 (1 year 11 months) Neuchatel, SwitzerlandValidation Manager @ Management of validation and change control programs with emphasis on critical systems, facility, and equipment validation. Manage and led the Metrology and HEPA Certification Labs. Achievements 路 Strengthened validation program by implementation of validation templates and master validation plans for critical systems, facility, major equipment, computerized systems and shipping process. 路 Developed and maintained budget, expenses and reduced staff overtime by 50%, maintained out-of tolerance exceptions to a minimum and reduced annual expenses by $1M. 路 Managed first on-time production start-up for Los Angeles facility after a shutdown in past 5 years. 路 Managed and completed all validation & re-qualification activities for $15M of annual plant shutdown improvement projects requiring four CBE-30 submissions. Led to minimal impact on product release. 路 Managed and developed staff of 9 individuals in Validation, Metrology & HEPA Certification From August 1997 to March 2003 (5 years 8 months) Los Angeles, CaliforninaExecutive MBA, Business Administration and Management, General @ IMD Business School From 2015 to 2016 Bachelor of Science, Chemical Engineering @ University of California, Berkeley From 1993 to 1996 Syed Yar-Khan is skilled in: Quality Assurance, Validation, Change Control, Regulatory Affairs, Aseptic Processing, Computer System..., Pharmaceutical Industry, Trackwise, Biotechnology, Lean Manufacturing, GMP, 21 CFR Part 11, GxP, Manufacturing, Cleaning Validation, Regulatory Requirements, Regulatory Submissions, Biopharmaceuticals, GAMP, FDA GMP, Change Management, Pharmaceutics, cGMP manufacturing, CAPA, Continuous Improvement, FDA, Mammalian Cell Culture, Purification, Quality Control, Quality Management, Quality System, Six Sigma, V&V, Centrifugation, Sop


Syed Yar-Khan鈥檚 Personal Email Address, Business Email, and Phone Number

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In a nutshell

Syed Yar-Khan's Personality Type

Extraversion (E), Intuition (N), Feeling (F), Judging (J)

Average Tenure

3 year(s), 8 month(s)

Syed Yar-Khan's Willingness to Change Jobs

Unlikely

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