At Parata, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life.

Reporting to the Parata Vice President, Operations, this position is accountable to ensure that Durham site’s procedures and practices are compliant with Parata, BD standards and applicable US & global regulatory requirements. This position is accountable to provide leadership, development and coaching for the site’s quality organization.

The Senior Manager Quality will develop and maintain the Quality Management System (QMS) for Parata and serve as the expert for Parata’s quality assurance and quality control programs, including supplier quality, development quality, operations quality and post market quality. The senior manager will drive continuous improvement initiatives throughout the company and across all product lines. Additionally, this individual will manage and oversee the work of the quality team.

The senior manager will establish the strategy and direction for quality programs and initiatives to ensure Parata’s business objectives are met.

Through outstanding communication, effective problem solving and active management of ambiguous & complex situations, the primary deliverables for the role are to ensure capable processes are implemented and maintained at the Durham manufacturing areas through proper process verifications/validations and ongoing inspection & testing in compliance with the Quality System, and applicable US & global regulatory requirements. This position may interact with regulatory agencies for all issues related to manufacturing, including ISO registrars.

The following Durham functions report to this position: Quality Assurance, Incoming Inspection, Calibration, Quality Control and Quality Engineering.

This position contributes to BD MMS WW functional strategy and priorities and ensures effective deployment within the plant. Equally, the Senior Manager of Quality is expected to promote the creation of a culture of Quality throughout the plant.

To succeed in this role, the Senior Manager Quality must have a unique blend of business and technical savvy, a big-picture vision, and the ability to build and sustain cross-functional collaboration. Ability to interact, collaborate and influence BD MMS cross functionals teams and Quality Leadership

Primary Responsibilities

1. Responsible for developing and maintaining plant strategic quality and compliance plans and policies.

2. Accountable for the effective execution of processes carried out under departmental leaders (Quality Engineering, Incoming Inspection, Calibration, Quality Assurance, Quality Control), by prioritizing and managing people, resources, and budget to accomplish expected requirements and performance.

3. Engage and provide leadership directions/objectives, coaching and personal development of site’s Quality associates to perform to their best ability and meet both personal and plant objectives.

4. Define framework for department objectives, operation schedule, processes, and budgets. Report on key quality metrics and drive improvement.

5. Act as the plant “management representative” for notified bodies and liaison with regulatory authorities and customers, by hosting and managing related audits and ensuring effective resolution.

6. Build an influential and effective network and communication with BD MMS WW Quality, Regulatory functions, other Parata/BD plant Quality Leaders and key BD MMS WW functions (Integrated Supply Chain (ISC), R&D, Design Assurance, Post Market Surveillance, Engineering, Supply Chain, etc.) to ensure alignment around global and local priorities.

7. Build an influential and effective network and communication with plant leadership team members in driving overall plant performance relying on a strong culture of Quality and Continuous Improvement.

8. Accountable to successfully manage and communicate quality issues.

9. Accountable for identifying quality improvement opportunities within operations and partnering with peers in Manufacturing & WW Operations and from other sites to develop and implement solutions – evaluate, propose, and implement new processes and technologies as alternatives to optimize efficiencies in the departments.

10. Ensure that site quality organization is staffed, organized, and resourced to ensure it can fulfill its obligations to comply with US & global regulatory requirements and Parata / BD policy and procedures.

11. Develop a cohesive team, maintaining and reinforcing a strong quality presence in the manufacturing areas, encouraging positive relationships and networking effectively across sites and organizations.

12. Manage performance issues and solicit the appropriate input from HRBP, stakeholders and management – write and administer performance appraisals on time and in a thorough and thoughtful manner.

13. Direct overall operational leadership in planning and management of quality systems activities, including resource management, which includes the following:

a. Validation program

b. Internal and external compliance / quality audits

c. Non-conforming material

d. Corrective and preventive action program (CAPA board)

e. Supplier Quality

f. GMP training program

g. Quality engineering

h. Process and Product Change Control

i. Document Control

j. Complaint / Field Service management

14. Implement Parata / BD corporate Quality policies ensuring finished products conform to company standards and satisfy GMP and safety regulations including UL compliance.

15. Ensure corrective actions are implemented. Manage non-conforming product inventories and ensure timely disposition of non-conforming products.

Skills and Experience

• 10 years+ experience in Medical Device manufacturing in leadership roles.
• Must be familiar with ISO9001, 21CFR parts 820 (QSR), 210/211, ISO13485, 93/42/EEC and having lead/participated in related audits & inspections.
• Experience in either production or engineering management.
• Educated to bachelor’s degree or equivalent in appropriate subject; Master Degree preferred
• Excellent verbal and written communication skills combined with the ability to adjust communication styles for a variety of internal and external audiences
• Multi-country/multi-cultural experience preferred.
• This position requires travel to customer and non-customer sites up to 25%

Knowledge, Skills, and Abilities Requirements

• Strong negotiating, influence, and leadership abilities
• Strong analytical & problem-solving skills
• Ability to build and maintain a team and to work in a matrix organization
• Ability to align his organizational strategy to the business and department’s vision and lead his team accordingly
• Ability to effectively use Change Management models to mobilize the organization
• Ability to define a project and direct teams through execution
• Action oriented when facing issue, change and uncertainty
• Ability to measure team’s performance using metrics and analytical indicators

Work environment and physical demands

The characteristics described below are representative of those encountered while performing the essential functions of this position. When properly requested and when feasible (without undue hardship to the company), reasonable accommodations will be made to enable individuals with disabilities to perform essential job functions.

• Work will primarily be in an office setting with limited opportunities to be exposed to adverse environmental conditions.
• Work will be primarily working with fingers by picking, pinching, typing, and grasping often with repetitive motion.
• Must have visual acuity for viewing a computer screen, the ability to alk, hear and sit for extended periods of time.
• Must be able to carry, lift and push/pull up to 5 pounds frequently and up to 30 pounds occasionally.
• Additional physical duties may be required as necessary.

Supervisory/Management position

• Yes

Primary contacts in this position

• Manager/Supervisor- daily, weekly or as needed
• Parata office employees - daily
• Parata Customers – daily
• Corporate HR staff – as needed

Advancement opportunities

• Director of Quality or other Integrated Supply Chain leadership role