Director of Quality

Job Title:Director, Quality Allergy Business Unit

Level :M2

FLSA Category (US Only):Exempt

Business Unit : ABU

Function : Quality

Country :USA

Work Location : Spokane, WA

Reporting Manager:Vice President, Quality

Team Size 50+

Direct Reports : 2

2. PURPOSE OF THE JOB:

The Director of the Quality Unit for the Allergy Business Unit is responsible for ensuring that the Quality Unit maintains standards expected by regulatory authorities, provides guidance to all Allergy Business Unit departments on procedures for meeting regulations, and promotes and enforces the expectations of the company for compliance. This position oversees the Quality Assurance and Quality Control areas specific to the Allergy Business Unit, in alignment with the Vice President of Quality and the corporate Quality initiatives. This position will work and partner with the leadership team of Allergy Business, including the CEO of Allergy Business, in implementing and driving quality structure.

3. KEY ACCOUNTABILITIES:

Responsibilities -

1. Establish strategies and work plans to promote Compliance, Quality Culture and standards for aseptic processing conditions in the Allergy Business Unit, and overall Contamination Control Strategies. Ensuring the alignment of the Allergy Business unit with the overall CCS strategy for the site .
2. Establish strategies and work plans to improve Quality Metrics and reduce areas of known risk from a compliance perspective.
3. Establish a Data Governance team, metrics and dashboards focused on closing the site gaps in this area and sustaining compliance related to Data Governance.
4. Promote and maintain the position and standards of Quality and Compliance matters to external clients, internal clients and regulators.
5. Bring forth and establish overall quality standards with other members of management, including contamination control strategies and supporting documentation compliant with Annex 1.
6. Establish standards for the disposition of finished product
7. Maintain product quality by enforcing quality assurance policies and procedures and government requirements
8. Review product and process quality reports by collecting, analyzing, and summarizing information and trends.
9. Transfer knowledge and understanding of compliance concerns, history and mitigation plans through documentation of this knowledge, trainings, etc.
10. Complete quality assurance operational requirements by scheduling and assigning employees
11. Maintain quality assurance staff by recruiting, selecting, orienting, and training employees.
12. Maintain quality assurance staff job results by coaching, counseling, and disciplining employees; planning, monitoring, and appraising job results.
13. Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
14. Prepare the Quality Unit budget for the Allergy Business Unit; scheduling expenditures; analyzing variances; initiating corrective actions.
15. Contribute to team effort by accomplishing related results as needed

4. KEY INTERFACES

External Interfaces FDA Auditors

Internal Interfaces All functional areas

5. EDUCATION & EXPERIENCE

Education Qualification(Highest) Bachelor of Sciences, emphasis on Scientific discipline

Experience Required:

• 15 years related experience.
• Managerial Experience required: Management experience and demonstrated ability to work with personnel at all levels of the organization.
• Minimum 10 years experience managing quality functions in a parenteral manufacturing facility required.
• FDA Regulated Industry Experience: Position is required to be an expert in the application and interpretation of FDA and other regulatory agency regulations.
• Working knowledge of EU guidance requirements and Annex 1

6. SKILLS REQUIRED:

Skills

Description

Proficiency Level

Functional Skills

• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint

Behavioral Skills

• Interpersonal skills are required so the position can effectively work with and influence staff at all levels.
• Position will be in direct contact with clients and regulatory agency personnel and must be able to communicate differences of opinion in a positive and constructive manner.
• Position must be able to manage conflicts and influence outcomes.

• General Awareness: Knows the fundamental or general understanding of concepts.
• Working Knowledge: Has broad / working knowledge of the subject. Uses concept daily.
• Functional Expert: Candidate is certified functional expert with strong knowledge on concepts.

Mastery: Candidate is subject matter expert and has command over the subject/ concepts.

7. WORKING ENVIRONMENT (USA) :

Physical

Vision Requirements:

1. ☐ 14/14 Corrected Near-Point
2. ☐ Pass Color Deficiency Test

1. Other Physical requirements:

• Exposure to Allergens
• Working in Aseptic Areas
• Prolonged Sitting

Environmental

• Managing conflict and influencing outcomes