Job Description

Job Title: Director of Biopharmaceutical Quality

Department: Quality

Location: Roseville, MN

Reports to: Vice President of Quality

Job Status: Exempt

Date Completed/Updated: November 2020

Job Summary: This role is responsible for the overall product quality of all CPC biopharmaceutical (Bio) products. The Bio Customer Quality team will report directly to this role to allow a direct connection to all incoming product quality issues. This role will then work within the Quality department and with the other Quality functional leaders to prioritize and align Bio work. Additionally, this role will collaborate with other cross-functional leaders and groups to ensure the Bio Quality teams are receiving the necessary support. Key performance indicators (KPIs) for this role include: Bio defective parts per million (DPPM), Bio part function complaint rate and severity, and Bio customer Net Promotor Scores in quality areas.

Essential Job Responsibilities:

* Provide strategic level thought leadership and execution to Qualitys vision, strategy and annual operational plans.
* Lead & manage the Customer Quality team to achieve goals.
* Collaborate with all Quality leaders to align and prioritize Quality resources supporting Bio.
* Collaborates & influences cross functional leaders and groups to achieve Bio quality goals.
* Develop programs, policies and initiatives that generate significant improvement in meeting customer requirements.
* Develop business relationships with external organizations and service providers that assist Quality goal achievement.
* Represent Quality on the Bio Leadership Team.
* Establish and/ or improve Quality metrics.
* Lead or sponsor cross functional teams supporting customer impacting issues.
* Establishes effective and appropriate business relationships with key customers.
* Keeps current in the field with external or internal education and training.
* Be a Quality advocate internally and externally.
* Adheres to all safety regulations.
* Demonstrates CPC core values.
* Performs other job duties as assigned to meet business needs.

Essential Supervisory Responsibilities:
* Supervises employees in the Quality department.
* Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws, including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
* Coaches team members for career growth and performance optimization.

Required Job Qualifications:
* Bachelors degree in engineering or related technical/ life science field.
* A minimum of ten (10) years of progressively responsible positions in Quality.
* A minimum of seven (7) years of demonstrated success in managing/ leading direct reports and achieving results through others.
* A minimum of three (3) years in the medical device, biopharmaceutical or other highly regulated industries.
* Understanding of up to date Quality theories, methods and approaches.
* Passion for improvement and drive for change to meet customer requirements.
* Exceptional analytical skill - ability to manage complex data including finance.
* Strong working knowledge ISO9001 and ISO13485.
* Proven ability to lead, influence and motivate both direct reports and other individual contributors and leaders.
* Excellent communication (verbal and writing) skills.

Preferred Job Qualifications:
* MBA or technical MS/ PhD degree
* Strong statistics and/ or product reliability knowledge
* ASQ participation and certification(s)
* Six Sigma, or similar, certifications

Travel Requirement (assuming no Covid restrictions): Yes, up to 10% Yes, International Yes, domestic

Physical Demands:

* The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* The employee must frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers and talk or hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to stand, walk and/or stoop.

Work Environment:
* The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* The noise level in the work environment is usually moderate.

This job description is not designed to contain a comprehensive list of tasks, responsibilities or duties. CPC reserves the right to amend to meet legal, business and organizational requirements as necessary.