Sr. Director Corporate Quality

Company: Nice-Pak Products, Inc. ( Learn More )

General Information
US-NJ-Montvale
N/A
4 Year Degree
Full-Time
Not Specified
Not Specified
False
False
Job Description Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world.

We have several locations across the US and are looking for new Associates to join our team!


POSITION PURPOSE

The Senior Director of Corporate Quality position is responsible for developing and implementing cGMP Quality Systems for drug/device products. This individual will manage through direct reports all aspects of cGMP Quality Operation functions (i.e., Quality Systems, Change Control, Document Control and Training, Vendor/Supplier QA, Validation and Third Party QA) through all phases of product development, commercial and life-cycle. This position and the team reporting to it will serve as the key point of contact representing QA in various developmental projects and liaising with various regulatory agencies for quality related matters.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

• Provide strategic leadership, development and implementation of cGMP QA Systems for drug/device products.
• Develop and maintain an effective Quality Management System (QMS) that complies with all regulatory requirements and applicable standards including FDA, EPA, ISO and Health Canada.
• Oversee and manage all aspects of quality functions for e.g., Quality Systems (Deviations, CAPA, Change Control, , Product Complaints, Management and Product Quality Review, Internal Audits), Document Control and Training, Lot Disposition (Raw materials to Finished Product release) for contracted products, Validation/Engineering oversight (facilities, equipment, computer systems, processes, risk management, manufacturing/technical transfer) and Vendor/Supplier and Third Party QA.
• Develop and implement Quality Risk Management (QRM) process to support assessment of complex systems, critical deviations and corrective and preventive actions (CAPA).
• Monitor supplier compliance programs including critical vendor statements, prioritization of quality agreements, quality audits, certifications and qualifications of approved suppliers.
• Create a culture of sustainable quality through quality and compliance programs such as risk assessments, change management, data integrity, right first time, quality councils and critical quality metrics.
• Conduct periodic Product Quality Review and chair the Management Review meetings.
• Identify, assess and communicate QA strategies, metrics (KPIs), gaps and compliance risks to senior management.
• Tracking, trending all KPIs (QA metrics) and design action plans to address trends.
• Monitor the effectiveness of the QMS by establishing appropriate quality objectives, metrics, and compliance goals.
• Partner with Product Development, Regulatory Affairs, Clinical Research, external vendors and partners to support corporate objectives and ensure compliance with all quality, regulatory and quality compliance requirements.
• Lead and contribute to site inspection readiness and commercial readiness preparations.
• Support and/or host regulatory audits; Federal, Notified Body for CE Mark, Local State including partner audits.
• Develop a high performing team to manage cGMP QA Operations responsibilities.
• Prepare accurate budget and headcount forecasts for QA organization. Oversee the QA organization within allotted budget and headcount.
• Provide training, development and growth opportunities for associates.


PERFORMANCE MEASUREMENTS
• Development and execution of Quality Assurance processes which enable rapid product development and product commercialization.
• Develop and Implement an FDA inspection readiness program.
• Develop and Conduct periodic Product Quality Review and chair the Management Review meeting.
• Develop and implement Quality Risk Management (QRM) process to support assessment of complex systems, critical deviations and corrective and preventive actions (CAPA).
• Establish and execute coaching programs for quality and manufacturing leaders to educate on sustainable quality. Requirements QUALIFICATIONS

EDUCATION/CERTIFICATION: Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred.

REQUIRED KNOWLEDGE: Working knowledge of ICH risk management tools, Failure Mode Effects Analysis (FMEA), and/or lean/Six sigma concepts.

EXPERIENCE REQUIRED: • 10+ years medical device and drug quality and regulatory experience in life sciences technology driven company.
• Minimum of at least 5 years of successful organizational leadership with measurable improvement results.
• Seasoned professional in managing cGMP Quality Systems (QA and QC) for drug/device products with a thorough knowledge of cGMP regulations (21CFR211, 21CFR820, EMA), ISO 13485, CE Marking and ICH guidances.
• Experience in oversight of implementing cGMP computer systems with compliance to Part 11 and EU Annex 11 requirements.

SKILLS/ABILITIES: • Ability to work independently on QA projects and initiatives with minimum supervision.
• Pro-active in identifying opportunities along with strong problem solving and negotiation skills.
• Ability to work 'hands on' in an entrepreneurial, fast paced environment.
• Leads by example and highly collaborative with the proven ability to work in a cross-functional team.
• Self-starter and team player with strong leadership, administrative, interpersonal, and team-building skills.
• Strong verbal, written communication skills and computer skills are required.
• Must be goal-oriented, quality-conscientious, and customer-focused.


WORKING CONDITIONS

NONE: No hazardous or significantly unpleasant conditions.


INTENT AND FUNCTION OF JOB DESCRIPTIONS

Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected. They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions. Well-constructed job descriptions are an integral part of any effective compensation system.

All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate.

In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization.

Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.


Nice-Pak Products, Inc. (NP) is the global developer, manufacturer and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection products.
  • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
  • Please view Equal Employment Opportunity Posters provided by OFCCP here.
  • The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
  • Please refer to the Company’s Substance Abuse Policy which protects the safety and well-being of all associates and potential associates.
  • Job Requirements