Project Management Manager

Rolling Meadows, IL ***** • LinkedIn.com/in/muhammad-haq1 • ********.*.***@*****.***

CAREER HIGHLIGHTS

●Brings nearly 7 years of experience in business analytics, project management and quality assurance in the pharmaceutical, biotech, and medical devices industries, with roles at AbbVie, Abbott, Pfizer, Takeda, and Cardinal Health

●Implemented inaugural data documentation efforts at Cognizant, significantly improving contingency planning abilities

●Spearheaded updates on validation protocols and new master data, enabling critical software implementation and infrastructure changes at Takeda

KEY EXPERTISE

●KPI Dashboards

●Agile, Kaizen & Waterfall methodology

●Project Management

●Regression Testing

●Business requirements documentation

●Audit

●Change Management

●SAP/TrackWise/Veeva/Smartsheets/Jira

PROFESSIONAL EXPERIENCE

AbbVie • Lake Bluff, IL

Data Analyst & Project Manager (Contract) May 2022 – Current

AbbVie is a pharmaceutical company boasting the 6th largest revenue in the industry ($58B). Built and oversaw daily reporting for 21 unique reports impacting 30+ employees and informing multiple customized dashboards across organization.

●Identified organization-wide gap in accessibility of reporting; developed and implemented 4 customized TIBCO Spotfire Analyst dashboards for 10+ teams across company that filled critical gap

oCollaborated with multiple departmental leaders to collect and refine dashboard requirements

oCreated 21 customized Excel reports using TrackWise data for Issues & CAPA Management, Audits & Supplier Management

●Pinpointed inefficiency in regulatory affairs processes related to terminology gaps; built out centralized RIMS glossary of 186 items that streamlined regulatory affairs and CMC processes

●Owned business validation testing following Agile Methodology for SolTRAQs (TrackWise) and Veeva Vault system upgrades, including collaborating with multiple teams to identify upgrade needs and customize actual upgrades impacting 500+ users

●Led migration of 30 Power Bi data tables from Impala to brand new ODBC Hive platform that improved database response time from an hour to five minutes

●Managed quality issues related to migration of 31k AbbVie SolTRAQs and 12k Allergan Global TrackWise records into Salesforce based TrackWise Digital (SaaS); presented regular SolTRAQs and GTW updates to SLC

Independent Consultant • Rolling Meadows, IL

Business System Analyst (Contract) July 2021 – May 2022

Provided regulatory affairs and Agile/Waterfall focused business analysis expertise to multiple large medical devices and pharmaceutical companies with revenue of over $1B.

●Acted as co-owner of business system analytics team, owning, implementing, and leading all sprint cycles in Jira

●Led cross-functional sprint team of 4 in executing multiple enhancements to Adobe Magento product eCatalog

●Served as US point of contact for issues related to product ordering system, collaborating across to disciplines to minimize shutdowns

●Managed sprint team of 5 in collaborating across the business to implement UATs

●Led all regulatory change assessments on major post-spin-off name change project

●Headed up critical lab documentation project, including pulling data from reports and compiling for multiple teams in Veeva

Cognizant • Rolling Meadows, IL

Business System Analyst Project Manager January 2021 – July 2021

Cognizant is an IT services and consulting company with nearly $17B in annual revenue. Recruited to step in mid-project on multiple projects and lead documentation efforts and business system analytics using Jira/Smartsheets in Agile and Waterfall environments

●Tasked with creating system functional requirements mid-project for major MES Savigent deployment efforts at all US Cargill Plants; implemented inaugural documentation efforts, transforming contingency planning

oActed as representative for 5 plants, identifying functional and non-functional system requirements and verifying and customizing needs based on input

●Selected to implement and lead efforts to broaden RWS machine language translation functionality in Veeva RIM and PromoMats, including creating validation test cases, new SOPs for FDA ICH submissions, and product-labeling translation requests; shortened translation wait time from 4+ days to less than 1

Takeda • Round Lake, IL

Business System Analyst (Contract) July 2019 – December 2019

Takeda is one of the top 20 largest pharmaceutical companies with over $21B in annual revenue. Oversaw test cases, UAT/regression testing, and data validation on multiple projects in an Agile environment. Acted as change control owner in TrackWise and Veeva Vault for exTAB SQL database specification updates. Led in-person and virtual technical support.

Business System Analyst, cont.

●Developed test cases in HPALM, updated project specifications, and executed UAT/regression testing for MES JD Edwards-EBM integration

●Performed data validation, running code in validation and production cycles to identify errors and prevent product delays

●Offered hybrid technical support during UAT and Hypercare for Flexbumin plasma production, logging and addressing 40+ issues during 3-day and month-long testing cycles

●Updated and reviewed IQ/OQ/PQ validation protocols and new master data to ensure success of critical new software implementation and infrastructure changes

oCompleted all outstanding change controls, transforming company’s change control capabilities, enhancing database efficiency, and minimizing product delays

HCL Technologies • Chicago, IL

Regulatory Specialist (Contract) April 2019 – June 2019

Recruited to support regulatory affairs efforts related to Global Medical Devices AdPromo Labeling.

●Conducted global labeling gap risk assessments in accordance with regulatory compliance requirements and identified need for standardization across labeling practices

●Developed and implemented labeling requirement documents and master content redlines via TrackWise 8, DOORs, and Nuance Power PDF Advanced to fill gaps across new and existing medical device products

Cardinal Health • Chicago, IL

Quality Regulatory Associate (Contract) November 2018 – January 2019

Recruited to support regulatory affairs efforts related to product registration at $200B+ multinational health care services company.

●Conducted analysis of business requirements for legacy products and identified disorganization across product registration; developed and implemented 3 Excel product registration databases for Cordis, Patient Recovery and legacy Cardinal products, transforming efficiency and standardization

Abbott Labs • Lake Bluff, IL

Regulatory Affairs Project Specialist (Contract) November 2016 – November 2018

Recruited to support all regulatory affairs efforts across $43B medical device company. Managed import and export of IVDs and biologics blood testing kits from APAC, EMEA, and LATAM; guided TPMs to properly label products exported to the US; assigned ACE product codes to import products into the US; worked with Abbott Customs to properly classify import/export products; supported 510k submissions and filed CDC, USDA and EPA permits

Identified major inefficiency related to permit application and approval process and implemented new SOPs related to product labeling, shortening permit approval timeline from 2 weeks to 1 day

Incepted and implemented R&D documentation initiative, successfully collating documentation for 100+ products to prevent future inefficiencies

Approved import and export of IVDs and biologics for clinical trials, semi-finished and finished products to APAC, EMEA, and LATAM by creating CUCs, attestations, FDA declarations, and health certificates

Managed project metrics for import, export, and global product registrations for 100+ products

Created legal documents for global registration of products

Resolved MDM issues to create multiple master databases and investigated regulatory compliance emerging issues while supporting FDA audits and resolving FDA notices

Managed the RIMS databases of IRIS and FOCUS for US, global regulatory affairs and authorized distributers, performed validation following Waterfall Methodology

Pfizer • Lake Forest, IL

Quality Engineer Regulatory Affairs Specialist (Contract) October 2015 – November 2016

Developed and implemented strategies across $12B pharmaceutical and medical devices company to eliminate inefficiencies, implemented serialization with Track & Trace and new labeling QR codes.

Identified superfluous spending related to packaging; collaborated with bulk carton vendors and developed mater list of critical manufacturing data that contributed to elimination of 200 packaging sizes

Created strategy and performed risk assessment to implement obsolescence changes for 5,000 products

Developed DCR / DIR packages, updated BOM, and conducted documentation impact assessments for manufacturing specification changes in collaboration with multiple departments

Led team in creating new GTINs for serialized products in accordance with GS1 standards

Created 32 container, closure, and seal specification documents for FDA submission following FDA eCTD and ICH guidelines

Led and trained sales enablement team in approving sales enablement requests in SAP Sales & Distribution for medical devices and pharmaceutical products and in use of SAP DMS system

Generated daily sales metrics reports for product launch status for Commercial Quality

EARLY CAREER

Kraft Foods • Project Manager Validation Analyst 2014 – 2015 Diageo • Project Manager Specification Analyst 2014

SKILLS

Language: Urdu, English, & Hindi Technical: JD Edwards, Smartsheets, TrackWise 8, & Veeva Vault/RIMS

PROFESSIONAL AFFILIATIONS

Member Regulatory Affairs Professionals Society 2016 – Present Member American Chemical Society 2016 – Present

EDUCATION & CERTIFICATIONS

University of Illinois at Chicago Bachelor of Science in Biology and Psychology SAP Certified Change Coordinator SAP 2015

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