Quality Manager

2 weeks ago

Brea, United States Sun Cloud LLC Full time

**Essential Duties & Responsibilities**:
Responsible for providing day to day quality input and oversight for successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners globally and ensuring that the operational business is in compliance with cGMP, Quality Agreements, regulatory standards and the client's Quality Management System.

Ensure high performance of third-party finished product contract manufacturers by establishing Quality KPI scorecard with regard to compliance and performance metrics.

Drives timely decisions and facilitates active communication and information flow between contract manufacturer and client's functional teams.

**Requirements and Qualifications**:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

Bachelor’s Degree in Engineering or science discipline or related field required.

Minimum 8 years’ experience in Pharmaceutical QA preferred, with preferences of External Quality Management and sterile injectables.

Strong working knowledge of current Good Manufacturing Practices, FDA and ICH Q8/9/10/12 guidelines.

Direct experience participating and supporting regulatory inspections and submissions preferred.

Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills.

Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.

Strong problem solving and analytical skills with demonstrated ability to be detail oriented; while managing multiple projects simultaneously.

Ability to travel domestically or internationally 5-10% preferred.

Experience with Microsoft Office.

Excellent organizational, interpersonal, and communion skills (oral and written).

Demonstrated experience with use/governance of electronic Quality Systems preferred.

Pay: $97,750.00 - $115,750.00 per year

**Benefits**:

- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance

Schedule:

- 8 hour shift

Application Question(s):

- Do you have ability to travel domestically or internationally 10%-20%?

**Education**:

- Bachelor's (required)

**Experience**:

- Quality management: 8 years (required)
- Pharmaceutical Industry: 8 years (required)
- Strong knowledge in GMP & FDA guidelines: 5 years (required)
- Manufacturing Industry: 5 years (required)

Ability to Commute:

- Brea, CA 92821 (required)

Work Location: In person

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