Associate Director, ODR
1 month ago
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
The 'Associate Director' is a second line Manager at Office of Data Reliability at ODR-US & directly reports to the Chief Data Reliability Officer (CDRO). The position is responsible for day-to-day coordination with Regulatory, Manufacturing/Packaging, MSTG, Quality Unit, Product Development & Project Management HOD's as well as Managers. The 'Associate Director' also coordinates with ODR-US and India teams for timely review and certification of pre-submission applications. The individual also does critical peer review of all applications for accuracy, traceability & reliability as well as usage of appropriate language in CDRO certificate as well as other critical comments before it is ready for execution & certification by CDRO for onward submission to US FDA. The Associate Director is also responsible for managing and supporting CDRO for day-to-day operation of Sun Pharma 'Disclosure Program' which is applicable to all Legacy Ranbaxy sites as per 'Consent Decree' while maintaining high level of confidentiality.
* This position directly reports to the CDRO and in coordination with the CDRO, establishes departmental goals and objectives
* Closely monitors 'Disclosure Program' including close interaction with third party engaged in managing 'Disclosure Program'; completes the paper-based investigation form as well as update, complete, close and post online via EthicsPoint; maintains each complaint systematically in paper format and archive them for a minimum period of four years
* Manages the day-to-day operations of the Sun Pharma "Disclosure Program" encompassing all Legacy Ranbaxy sites and responsible for timely closure of disclosure cases; provides support to the CDRO in disclosure case investigations, as and when needed
* Closely works with and supports the CDRO in preparation of ODR Budget and/or ODR Board Presentation, as and when needed
* This administrative and supervisory position will have direct and indirect reports, and in conducting this role, the Associate Director will work closely with the Senior Manager, prepare and conduct performance appraisals, monitor/review work product and contribute to coaching/mentoring direct and indirect reports
* Reviews and completes the performance appraisal of all third and fourth line staff and guides them in improving their performance
* The Associate Director coordinates with Human Resources, Training Department, EHS team for any employee-related issues
* Closely works with the Senior Manager in management of day-to-day operations ensuring that all audits are completed on time without compromising the quality of review, including efficient use of manpower resources
* Collaborates, coordinates & educates/mentors the ODR-India and ODR-US teams as well as cross-functional departments such as Product Development, ARD, MSTG, Regulatory Affairs, QA/QC, Ohm
*
* manufacturing and packaging, project management teams for smooth completion, conclusion, and certification of pre-submission applications
* Consistently educates, mentors & trains the ODR-US team by personal interaction on a daily basis
* Prepares, reviews, or approves Change control records and/or departmental SOPs due for revisions
* Ensures compliance with cGMP/cGLP and good documentation procedure during the review process
* Support the ODR-US/India team on need basis by completing the audits of time bound pre-submission applications as per approved audit check list of ODR
* Communicates any audit comments/ observations/ findings to respective stakeholders and assesses acceptability/ appropriateness of responses
* Closely works with the Senior Manager and informs the Chief Data Reliability Officer immediately of any critical data integrity issues or data irregularity
* Performs critical peer review of all applications before it is presented to CDRO for certification
* Reports all audit finding in the ODR audit worksheets and highlights noteworthy/ major/ critical observations on CDRO certifications
* Completes the audit tasks within the specified timeframe without compromising the quality of the audit and archives all documents in a closed electronic system
* Performs any other responsibilities which are required as assigned by the CDRO depending on departmental needs
* Adheres to the Safety and Health Program applicable to the site
Qualifications
* Minimum Bachelor of Science (B.S.) in Chemistry, Pharmacy, Biochemistry or related field. A Master of Science (M.S.) in Chemistry, Pharmacy, Biochemistry or related field is desirable.
* Minimum of twelve (12) years of experience in a pharmaceutical company within Quality unit
* 2-3 years of Quality Assurance exposure in Pharmaceutical industry is preferable, involving review of manufacturing/ packaging batch records and investigations
* Knowledge in and review of, but not limited to: Laboratory test procedures, cGMP requirements, cGLP, ICH/US FDA guidelines, raw material analyses, method validation guidelines, analytical method transfers, finished products and stability testing procedures; standard operating procedures, general procedures, test procedures, validation protocols; manufacturing and packaging batch records, excipients COAs, packaging components COAs, manufacturing reports, scale-up reports, product development reports; Quality overall summaries, executive summaries
* Proficient in MS Office applications (Word, Excel)
* Ability to coordinate internally and with external stakeholders in an effective and efficient manner, with capability to manage the team on simultaneous projects within multiple/ varied set timelines
* Exhibits flexibility in applying strategic solutions in handling work-related challenges (manpower resource crunch and time management)
* Must be a self-motivated, proactive leader, with ability to foster positive interaction with colleagues and stakeholders to ensure work ethics, teamwork, and discipline
* Conduct oneself in a professional manner in alignment with corporate values.
* Ability to work and interact successfully in a global, diverse and dynamic environment.
* Demonstrated excellent interpersonal communication skills: verbal, written and presentation skills.
* The requirement for English language proficiency for this job role is Intermediate-B2 (comparable to Global CEFR Independent B2) level based on the Common European Framework of Reference for Languages (CEFR).
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