Job Details

Requisition Number 19-0182
Post Date 10/9/2019
Title Director, Site Quality
City Orangeburg
State NY
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

This purpose of this position is to lead the Quality Assurance and Compliance function for the Orangeburg, NY Manufacturing Site. The Director, Quality Assurance will be responsible and accountable for Quality Assurance, Compliance, and Continuous Improvement and evolutionary compliance for PDI products and potential geographic expansion.

As an integrated partner within the New York site, the Director, Quality Assurance will drive operational efficiencies, manage gap closures, and champion Quality initiatives. He/ she will interact routinely with Contract customer(s), Quality Control, Microbiology, Operations, IT/BT, EHS&S, R&D, and Corporate Quality and Regulatory Affairs to audit and improve systems and processes. The incumbent will provide leadership and direction ensuring that the entire product lifecycle and chain of custody are compliant, well-controlled and efficient; within PDI standards and Customer requirements as well as State and Federal Regulations.

This position requires both strategic and tactical skills to manage the activities and performance to ensure the focused compliance within a high-volume, complex manufacturing site that produces products in six (6) different Regulatory categories: Rx/ OTC Drug, Medical Device, Consumer, Cosmetic, EPA-Registered, and Food Safety.


ESSENTIAL FUNCTIONS AND BASIC DUTIES

Staff Management:
a. Provide leadership in Safety, Quality and Service through the use of continuous improvement. Ensure all personnel perform their jobs in a safe manner complying with company safety standards and rules.
b. Manage the site QA/QS activities required to maintain and improve the Quality Management System and adhere to the ICH, the Code of Federal Regulations, ISO requirements and applicable International and State Regulations.
c. Prepare and manage correspondence and remediations for key Contract customers.
d. Manage team’s annual goal setting.
e. Develop, train, and ensure compliance with Corporate Practices, SOPs, Work Instructions, Manufacturing Instructions, and other Regulated Documents. .

Performance Management:
a. Manage team’s annual goals to ensure SMART objectives in alignment with the Strategic Plan. Set, review and discuss set goals at regular intervals.
b. Support the technical training efforts regarding the education of plant personnel regarding cGMP compliance, PDI requirements as well as other regulatory requirements.
c. Ensure the site is functioning in a high state of readiness and compliance, and meets established criteria for testing and product disposition (release) schedules.
d. Ensure that all documentation regarding the Quality Management System is effectively maintained.
e. Support all external and internal audits.
f. Direct and assist the quality team as an urgent resource to respond to issues and urgencies. With the assistance of other key site departments, coordinate the necessary resources to minimize any resulting downtime.

Communication:
a. Ensure appropriate training and understanding of technical responsibilities and tasks.
b. Act as liaison and Project Manager for continuous improvement, s, gap closures, and addressing evolving standards.
c. Direct all activities associated with the Quality System Elements (QSEs).
d. Direct all activities associated with product or facility non-compliance conditions. Act as the site quality resource for the Material Review Board (associated with batch disposition of product under investigation).
e. Participate in quarterly town hall meetings
f. Conduct at least one Management review annually.
g. Responsible to attend, participate and share information in daily manufacturing meetings.
h. Ensure accuracy of department’s data reporting. Communicate results in the town hall and management reviews.
i. Foster an environment of strong customer service, open communication and partnership.

Training:
a. Ensure that all team members are trained and qualified to perform the assigned job functions and tasks.
b. Ensure that training is current and not past due.
c. Assist Supervisors in developing, training and mentoring associates through regular feedback, participation in group decision-making and fostering open communications.
d. Assist in setting priorities and goals.


PERFORMANCE MEASUREMENTS
1. Quality Compliance
2. Budget Favorability
3. Cost savings and Streamlining initiatives
4. Service and Communication
5. Staff Development
6. Contract Customer Accountability
7. Continuous Improvement
8. Batch Record Review – First-Time Right
9. Safety Champion
Requirements QUALIFICATIONS

EDUCATION/CERTIFICATION:
University Degree in Biology or Chemistry, or equivalent experience. ASQ or CQA Certification a plus.

REQUIRED KNOWLEDGE:
Experienced leader in Quality Assurance / Quality Control Processes. Excellent interpersonal and leadership skills. Knowledge of Quality Systems design, implementation and maintenance. Full knowledge of how to implement regulations and Quality Systems for the Pharmaceutical, Medical Device, Consumer and EPA Industries required. Keen understanding of cGMP for manufacturing and laboratory environments. Proficiency in Windows operating system and Quality System applications and technologies.

EXPERIENCE REQUIRED:
5-10 years of management experience working in Quality for a Pharmaceutical, Medical Device and/or EPA manufacturing environment. Experience with operations and procedures required of both analytical chemistry and microbiology laboratories. Experience in conducting facility and system audits and leading corrective action teams. Experience as customer and Contractor manufacturer liaison.

SKILLS/ABILITIES:
Absolute integrity and compliance focus. Ability to lead a team by example. Ability to successfully navigate a highly complex, dynamic environment. Exemplary communication, documentation, and presentation skills. Strong Root Cause Analysis and Problem Solving Skills. Ability to manage a team budget and drive cost out of processes. Excellent Customer Service focus and skills. Ability to plan comprehensively, collaborate cross-functionally, and execute flawlessly.


WORKING CONDITIONS

NONE: No hazardous or significantly unpleasant conditions.

#LI-PDI
#LI-SC2


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.
  • 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.
Apply Online
Send This Job to a Friend