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Job Description

Our Client â€" A growing Pharmaceutical Co. with WWide sales of $7B and 14K people at their HQ and plant location needs for their Aseptic Mfr.  QA/Validation Dept. Excellent Salary and full relocation.

Job Posting # 1199-A

Job Title:  Manager â€" QA Validation.      

Location:  Dallas - Fort Worth, TX    Relocation: Yes - Full      Overnight Travel:  5%

Company: This is a growing pharmaceutical company with sales of $7+ billion and 14,000 people worldwide.

Group: Be a part of the Quality / Validation group consisting of 14 professionals supporting an aseptic pharmaceutical plant of around 500,000 sq. ft and 400 people. The plant is part of a campus with around 5,000 people that also includes the company headquarters and corporate offices

Department: This position is in 1 of 3 sub-groups responsible for new products / processes which are moved from R/D and product development to full scale commercial manufacturing of aseptic drugs.

Job Description:

50%: QA Validation Development/Support

25%: Department and people management.

25%: Interface with other groups like production, Process development, R/D.

This QA / Validation Manager position has 3 direct reports with emphasis on Process Validation with some aspects of equipment and cleaning validation.

The position is responsible for coaching, mentoring and development of direct reports; part of project management teams for projects in excess of $10MM;

Involved with Master scheduling and allocation of resources for calender year;

Adept at project management skills and software;

 Requirements:

1. Broad based experience in the science, engineering and operations of manufacturing ant testing systems such as: USP Clean Steam, USP Purified and WFI Water, Clean Compressed Gases, Sterilization - steam in place, autoclaves, terminal sterilization and parametric release, vaporized hydrogen peroxide, gamma sterilization, radiation sterilization, bulk product sterilization and in line sterile filtration; familiarity with automated processes with ability to understand software control algorithms; aceptic processing including enviromental controls and standards, media, cleaning (including clean in place) mixing and product qualification.

2.  New product transfer experience

3. In depth knowledge, interpratation and application of related internal and external standards ncluding International Standards for both Drug and Devices (e.g. Medical Device QSR's, ISO Standards, 21 CFR 210/211 etc.)

4. Ability to challenge the status quo validation science and implement innovative, and practical validation approaches.

5. Proven analytical and problem solving skills and familiar with such continuous process improvement tools as Desgin of Experiments, Cause-Effect Analysis. Failure Effect Mode Analysis, 6 Sigma etc.

6. Proven leadership for dirct reports, influencing co-workers, organizational impact, planning and management skills to lead multi-disciplinary teams for multiple projects simultaneously, meeting deadlines and delivering within budget within an existing sterile medical device and drug product manufacturing envirioment.

7. Highly developed communication skills, both verbal and writing.

8. Ability to professionally interact with government regulatory officials during audits and to defend scientific studies designed to prove reliablity of processes.

9. Ability to to coach and help develop succession plans for direct reports, including coaching, mentoring towards specific measurable objectives, including technical development, leadership development and interpersonal skills. 

Job Requirements

Must Have:

• BS Science or Engineering.

• Min 10 yrs exp in biopharma/medical devices.

• Min 1 year of people management

• 5 years hands on previous experience with QA Validation.

• In depth knowledge of standards – QSR, ISO, CFR 210/211 etc.

• Excellent people and communication skills.

• Process Validation experience with new processes, productions and transfers etc.

  Some experience in aseptic liquid processing.

• Experience with direct FDA onsite interface.

Nice to have:

• Advanced degree
• Knowledge of any of the following unit operations like USP Clean Steam, USP Purified and WFI Water, Clean Compressed Gases, Sterilization - steam in place, autoclaves, terminal sterilization and parametric release, vaporized hydrogen peroxide, gamma sterilization, radiation sterilization, bulk product sterilization and in line sterile filtration

Keyword: QA, Validation, Aseptic, manager, FDA, sterilization, “Process validation"