Sr. Manager, Regional Quality Support

COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!

• Medical, Dental, Vision Benefits
• Health Savings Account (HSA), Flexible Spending Account (FSA)
• Prescription Drug Coverage
• Telehealth and Behavior Health Services
• Income Protection - Short Term and Long Term Disability Benefits
• Retirement Benefits - 401k Company Match on Day One (100% vesting immediately)
• Group Life Insurance
• Wellness Programs
• Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods!

Sun Pharma Vision: Reaching People And Touching Lives Globally As A Leading Provider Of Valued Medicines
Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility.Integrity.Passion.Innovation. It represents our promise to all stakeholders including patients, physicians, and employees.
Our Code of Conduct
Our Global Code of Conduct governs every aspect of our operations. Sun Pharma is a family of thousands of people, working across many countries, speaking multiple languages, and all united, with one common purpose: to make good health accessible and affordable to local communities and society at large. Through active fieldwork, dedicated research teams, and in recognition of the efforts who work behind the scenes to combat illness and disease, the Sun Pharmaceutical Group helps as many people as possible, to secure their right to good health. The way we work every day is important to us.
DOWNLOAD OUR CODE OF CONDUCT
This position shall ensure regulatory compliance of all Sun sites, with products distributed in the US market, for Field Alert Reports and Drug Product Recalls. Provides guidance to multiple site regarding Product Quality Complaints and assists sites for other North America Compliance activities, as needed.

• Management of Field Alert Repots (FARs) including the submissions of all initial, follow-up, and final FARs for the USA market. Answers related FDA queries in conjunction with the manufacturing site.
• Management of US Drug Product Recalls including all submissions to FDA. Coordinate with district office for closure of Recalls. Answers related FDA queries in conjunction with the manufacturing site. Coordinates all recall activities with third party service providers or site, as applicable. Attends Global Recall Committee meetings.
• Management of other documentation/responses to FDA such as Biological Product Deviation Reports (BPDRs), Drug Notifications.
• Management of third party service provider for US Product Quality Complaints. Maintains Sun Pharma master list for complaint intake and sample procurement instructions, resolves issue, and provides guidance to site regarding complaint investigations, as needed. Reviews, edits, and sends response letters to complainants for overseas facilities, as needed.
• Assigns product and packaging codes for the National Drug Code (NDC), as applicable.
• Reviews investigations, provides guidance, and routinely follow-ups with sites to drive closure.
• Provides support as needed to New Jersey Distribution Center, QA-CMO, and Sales & Marketing/Supply Chain, US Manufacturing sites, and others, as needed.
• Support North America region in terms of collating Quality Metrics and drive implementation of action items at sites for improvement of compliance level and effectiveness checks.
• Support and co-ordinate implementation of Global Assessment, 483/WL Observation Assessment in liaison with Corporate Quality Compliance team in India.
• Support sites in North America region in timely filing of response to inspection observations and commitments.
• Support North America region compliance activities, as needed.

Qualifications

• Minimum of ten (10) years of experience in the regulated pharmaceutical industry within the Quality Assurance and/or Quality Control environment.
• Minimum of BS in Chemistry, Pharmacy, Biochemistry or related field; MS/PhD preferred.
• Experience with creation of Field Alert Repots (FARs) including initial submissions, follow-up, and final FARs.
• Experience in communicating with, and responding to FDA queries.
• Experience with conducting US Drug Product Recalls including all submissions to FDA and coordinating all recall activities with third party service providers and site, as applicable.
• Experience conducting Technical Reviews and Writing (includes but is not limited to the following: Protocols, Test Methods, Standard Operating Procedures, Corporate Policies, Global Quality Standards, Quality Agreements, Confidentiality Disclosure Agreements, Change Controls, Deviations, Investigations, CAPA's, Responses to Regulatory Agency Observations, FAR/Recall Support).
• Experience supporting investigations and conclusions with strong compliance decisions regarding product disposition.
• Advanced knowledge of FDA/regulatory authority drug regulations and guidance.
• Demonstrated ability to support regulatory and customer audits to successful outcomes.
• Advanced knowledge of regulatory requirements related to pharmaceutical manufacturing and 21 CFR requirements.
• A self-starter with a hands-on approach and a can-do attitude.
• A team building champion driving innovative cross functional synergies.
• Strong project management, organizational and problem solving skills.
• Extensive understanding of policies, guidelines and systems related to quality assurance programs, cGLP and cGMP audits.
• Ability to collate and present data for Regional Quality metrics/management review.
• Strong negotiation skills, relational skills and ability to communicate effectively with all levels of the organization and external stakeholders.
• The requirement for English language proficiency for this job role is Intermediate-B1 (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

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