(QMS) Compliance Head, Ohm Labs, New Brunswick, New Jersey
Defines 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
The site quality assurance road map for a 3-5 year horizon and also annual site QA operating plans/budgets
Ensuring 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 departments
Lead 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 Plans
Responsible for assessment of Global procedures and policies and implementation at the site, as applicable
Accountable for designing/implementing at site quality policies, standards & QA systems
Oversee identified training needs, assess gaps, design and facilitate appropriate and meaningful training programs
Responsible for managing electronic and physical record documentation system in compliance with regulatory requirements
Lead/Execute site internal audit to ensure identify critical findings and improvement of quality systems
Provide QA review/approval on Cleaning Validation program, process validation or verification program, computer system validation program, equipment calibration and qualification program, facility, utility
In-Depth knowledge of Data Integrity Principles and ability to assess Quality Systems for compliance
Ensure 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 plan
Regulatory 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 budgets
Knowledge 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 corrections
Knowledge 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 organization
At 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 objectives
Nurture 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 responsibilities
Behavioral 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’ need
Executive 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 change
Solution 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 opportunities
Communication 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).