Job Title:
Medical Quality Manager (MQM)
Location:
India
Job Type:
Full-Time
Department:
Quality Assurance and Control / Medical Affairs
Purpose & Scope:
The Medical Quality Manager (MQM) is responsible for driving medical quality, audit and inspection readiness, and risk mitigation across the in-country Medical Affairs Business Unit (BU).
The role ensures alignment with the Global Medical Affairs Quality Oversight Committee (GMAQOC) and manages cross-functional processes with medical involvement or inspection risk, in collaboration with International Medical Quality (IMQ) and local business partners.
Organizational Relationships:
The MQM will:
Work closely with in-country Medical Affairs, Platform Line organizations, and other quality and compliance representatives (e.g., Commercial Quality, Supply Chain/Product Quality, Compliance).
Be a member of relevant country medical and quality/compliance leadership teams or communities such as the Country Medical Council.
Key Responsibilities:
1. Quality Management
Drive Level 1 medical quality oversight and provide business support at the market level.
Lead development and execution of country medical quality strategic initiatives in collaboration with local and global stakeholders.
Implement Global Quality Plans and develop Country Operational Plans based on business risk and need.
Demonstrate the value proposition of Medical Quality within the organization and to external customers.
2. Audits & Inspections
Lead continuous medical inspection readiness initiatives in partnership with global inspection teams and business units.
Monitor audit and inspection trends, communicate findings, and ensure corrective actions are implemented.
Develop and maintain the Regulatory Inspection Site Notification Plan.
Coordinate Regulatory QA Pfizer Country Organization (PCO) audits and vendor audits, including management of Corrective & Preventive Actions (CAPAs).
Support corporate audits and external inspections in collaboration with global teams.
Oversee maintenance of professional records for Medical Affairs colleagues.
3. Issue Escalation & Quality Event Management
Manage Quality Events (QEs) and CAPAs within MQM remit and act as Business Line Quality Group lead.
Track performance of PCO QEs and CAPAs.
Act as a local expert on QMS01, promoting issue escalation and remediation awareness across PCO teams.
4. SOPs & Procedure Management
Develop, implement, and maintain in-country controlled documents within QMS04 scope, collaborating with Subject Matter Experts (SMEs).
Ensure alignment of local controlled clinical and medical documents with Pfizer global policies, SOPs, and regulatory standards.
Support global SOP development by providing country-specific feedback and impact assessments.
Manage local implementation and communication of updated global SOPs.
Support assessment of new or revised regulatory requirements impacting the Medical Quality Management System (QMS).
5. Training
Ensure training curricula and compliance within MQM remit are aligned with Pfizer standards.
Act as local expert on QMS07 and Pfizer’s Global Learning Management System (GLMS).
Identify and support additional training needs beyond mandatory MEL requirements.
Conduct or facilitate quality-related training sessions for Medical Affairs teams.
6. Monitoring
Identify local areas requiring monitoring and quality review in collaboration with medical management and IMQ.
Execute monitoring activities as per Global Quality Plans.
Required Skill Set
Education & Experience
Scientific or technical degree preferred (BS/MS)
3+ years’ experience in compliance, SOP management, auditing, QA/QC, or a related field.
Strong understanding of local promotional compliance environment and medical function compliance issues.
Experience working in a matrixed organization is highly valued.
Technical & Behavioral Competencies
Fluency in English (written and spoken).
Strong project management and organizational skills.
Proven ability to manage multiple complex projects independently.
Skilled at leading without formal authority at senior levels.
Excellent communication, presentation, and interpersonal skills.
Demonstrated collaboration and facilitation across functions and geographies.
Strong continuous improvement and organizational effectiveness mindset.
Culturally sensitive, able to work effectively across boundaries and with diverse teams.
Work Location Assignment:
Hybrid
Job Category:
Quality Assurance and Control / Medical Affairs
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Goa :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
New Hampshire |Oklahoma :
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Tuscaloosa |D.C :
Washington |Delaware :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
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Donegal |Meath :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | Uxbridge | Richmond Hill | Australia | North York | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
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McFarland | Green Way | Springville | Nairobi | Remote - South America (Latin Americal) | French | Melbourne | Remote, USA | Zaragoza | Medan | Lenexa | Switzerland | Remote - Africa | Bountiful | Remote | Castlebar | Leinster | Bishop | Lousiana | Thailand | Regulatory Labeling Manager (NA and LATAM Only) | Hungary | Texas | Riga | Faridabad | Remote - Europe | Belgium | Tulsa | Minnesota | Ireland | Remote - Middle East | Hammond | Manipal | Slovakia | Victoria | Blue Bell | Xzagreb |Republic of Colombia :
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Buenos Aires |Republic of Egypt :
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Ciudad de México | New Mexico |Dubai :
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Rabigh | Jeddah | King Abdullah Economic City | Khulais | Najran | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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