Senior Manager/Associate Director, Compliance
Company: Sun Pharmaceutical Industries
Location: New Brunswick
Posted on: January 12, 2021
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Job Description:
Senior Manager/Associate Director, Compliance, Ohm Labs, New
Brunswick, New JerseyJob SummaryDefines tactical/operational
strategy/road map for quality assurance management at site; defines
site quality assurance goals and strategy in line with Sun global
quality requirements, product quality management objectives and
regulatory requirements. Position title to be determined based on
candidate alignment of industry and professional
experience.ResponsibilitiesThe site quality assurance road map for
a 3-5 year horizon and also annual site QA operating
plans/budgetsEnsuring compliance to QA regulatory requirements in
manufacturing at the site and for tracking quality assurance
metrics e.g. deviation, CAPA effectiveness, market complaints with
site manufacturing and other departmentsLead implementation and
continuous improvement of the company's quality systems, including
oversight of QMS Responsible for designing, implementing and
ensuring compliance to all quality assurance related SOPs at site
manufacturing areas PlansResponsible for assessment of Global
procedures and policies and implementation at the site, as
applicableAccountable for designing/implementing at site quality
policies, standards & QA systemsOversee identified training needs,
assess gaps, design and facilitate appropriate and meaningful
training programsResponsible for managing electronic and physical
record documentation system in compliance with regulatory
requirementsLead/Execute site internal audit to ensure identify
critical findings and improvement of quality systemsProvide QA
review/approval on Cleaning Validation program, process validation
or verification program, computer system validation program,
equipment calibration and qualification program, facility,
utilityIn-Depth knowledge of Data Integrity Principles and ability
to assess Quality Systems for complianceEnsure availability of
adequate resources, including manpower to maintain compliance with
GXP requirements.Responsible to review and revise department SOP
and provide required training to individuals in the department
Serve as QA liaison and host external customer audit and regulatory
inspection This is a supervisory position with direct reports;
therefore, this position will establish goals and objectives,
prepare performance appraisals, monitor/review work product and
coach/mentor direct reports.Responsible, from time to time, for any
additional projects as agreed with Site Quality Head.Strive towards
achieving the corporate vision of ---Reaching People and Touching
Lives Globally as a Leading Provider of Valued Medicines--- through
collaboration and teamwork. Conducting oneself in a professional
manner guided by the Corporate Ideologies of Humility, Integrity,
Passion and Innovation. Align business activities and actions with
the Corporate Values of Quality, Reliability, Consistency, Trust,
and Innovation.Experience and Education:Minimum of Bachelor Degree
in Chemistry, Pharmacy or relevant scientific field; MS preferred
Inspections Management Skills - Demonstrates expert knowledge of
audit requirements of corporate, national and international
standards and regulations (FDA, EU etc.) related to overall
facility management to identify resources and prepare inspection
management plans, ability to assure resources and documents as per
auditing requirements, collaborate effectively for successful
completion of facility audits, review audit reports and assess
impact on other functions and facilitate corrective action
planRegulatory Knowledge - Demonstrates strong knowledge of
regulatory requirements / guidelines for various countries (FDA,
EU) in order to plan, budget and implement regulatory requirements
and ensure compliance Knowledge of Budgeting - Demonstrates expert
knowledge of consumables and costs in quality budgeting In order to
interpret cost and productivity analysis to generate cost reduction
opportunities and cost control measures across areas and review,
justify and finalize budgetsKnowledge of Resource Management -
Demonstrates expert knowledge of execution on plan/priorities
regarding availability of manpower, material and equipment in order
to estimate, plan, allocate and optimize resource utilization
through prioritization across whole unit (programs/ plants);
ability to review resources proposal/ mid-term correctionsKnowledge
of Statistical Tools - Demonstrates advance knowledge of
statistical techniques and tools and statistical models in order to
develop models/solutions to reduce risk , time and operating costs;
effectively utilize the statistical tools in data analysis,
reporting and for improving the quality performance of the company;
Investigation Skills - Demonstrates expert knowledge for management
of investigation programs, procedures and tools, with domain
knowledge of impact assessment and implication on other related
areas to assure comprehensive investigations to avoid repeat of
issues/incidents; reviews trends and understands issues impacting
overall organizationAt Least 10 years--- experience in
pharmaceutical quality management leadership roles, inclusive of
directing and leading Pharmaceutical Site Quality Assurance Teams.
Drive Results & Excellence - Demonstrates commitment to
organizational objectives and pursues them with energy and
persistence in accordance to established processes and policies.
Drives accountability within team and areas of influence Strategic
Thinking - Sees connections, patterns or trends in the information
available. Collaborations & Trust - Identifies, builds and
maintains strong and sustainable partnerships based on trust, with
different stakeholders across teams, business units, functions to
meet business objectivesNurture Talent - Committed to development
of self and others. Provides frequent and constructive feedback.
Shares own knowledge and expertise to improve other---s performance
and inspires them to take higher responsibilitiesBehavioral
Customer Centricity --- Reinforces the importance of being customer
focused; encourages a culture that values customers while
monitoring & acting on their feedback from customers. Always
focuses on delivering solutions that meet customers---
needExecutive Impact/Effectiveness - Understands and articulates
information shared by customers, peers and managers. Gain support
and cooperation, and overcomes objections/ barriers while facing
difficult situations. Leading Change - Sets the change agenda,
adapts and aligns efforts and resources towards organizational
goals. Shows sensitivity and respect towards diverse perspectives
and cultures while driving changeSolution Orientation - Takes
action to promote and implement innovative ideas. Takes initiatives
and encourages innovative solutions at work by trying different and
novel ways while handling work problems or
opportunitiesCommunication Skills- Demonstrates excellent verbal
and written communications skills while interacting with others.
Ability to provide and receive constructive feedback when needed.
Results Driven- Works towards completion of goals, and delivers on
time. Influence leadership-Inspire a healthy and motivating work
environment and atmosphere; monitor team performance; lead by
example to motivate team members to work towards shared and
individual goals.Disclaimer: The preceding job description has been
designed to indicate the general nature and level of work performed
by employee within this classification. It is not designed to
contain or be interpreted as a comprehensive inventory of all
duties, responsibilities, and qualifications required of employees
as assigned to this job. Nothing herein shall preclude the employer
from changing these duties from time to time and assigning
comparable duties or other duties commensurate with the experience
and background of incumbent(s).
Keywords: Sun Pharmaceutical Industries, New Brunswick , Senior Manager/Associate Director, Compliance, Executive , New Brunswick, New Jersey
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