TheLadders.com Logo The Most $100k+ Jobs

This position has just been filled.
Join TheLadders.com now for access to 54,079 open jobs.

Associate Director - RDB4345

Hiring Company Industry: Biotech/Pharma
Number of Employees: 100 - 1,000 Employees
Total Compensation: $110K
Location: Boston, MA
Position Filled
JOB DESCRIPTION
JOB DESCRIPTION:

  • Provide oversight of investigations, complaints and returns for Allston Operations and Quality (QA/QC)
  • Guide investigations specialist with aid in establishing the scope of the investigation as well as path forward.
  • Responsible for site metrics related to investigations, CAPAs, etc. as they relate to Compliance.
  • Maintain department SOPs consistent with site, industry and regulatory requirements.
  • Ensuring that site practices are consistent with corporate quality standards as appropriate.
  • Developing and managing departmental budgets in cooperation with direct staff.
  • Supporting an environment of staff development and learning. Providing feedback to direct reports in a timely manner.
  • Managing performance issues and soliciting the appropriate input from HR and management. Writing and administering performance appraisals on time and in a thorough and thoughtful manner.
  • Developing and executing hiring plans. Ensuring that requisitions are interviewed for and filled in a timely manner.
  • Keeping senior management apprised of product issues, dispositions and quality improvement plans.
  • Developing a cohesive team, maintaining and reinforcing a strong quality presence in the manufacturing areas, encouraging positive relationships and networking effectively across sites and organizations
  • Extensive knowledge of fundamentals in the Biotechnology/Pharmaceutical fields and hands on technical expertise is required.
  • Comprehensive knowledge of FDA and EMEA regulations of the biopharmaceutical industry, including, but not limited, to aseptic processing of biologics is essential.
  • Excellent technical writing skills are necessary as well as a working knowledge of statistical analysis, process, software and method validations.
  • Familiarity with electronic systems including Trackwise, and Catsweb is desirable.

  • A minimum 10-15 years experience in a pharmaceutical/biotech GMP environment is required.
  • Prefer experience in a biologics/aseptic processing facility.
  • Manufacturing or technical support experience preferred.
  • Must have prior experience handling operations and QC related investigations and have the ability to coach QA Investigation Specialists.
  • A college degree in a scientific discipline is required with an advanced degree (MS, MBA or PhD) preferred. Must have demonstrated leadership in an operational/GMP plant setting.
  • Must be well organized, detail-oriented, and be able to work with minimal supervision.
  • Outstanding communication skills needed to facilitate and develop relationships with other departments and facilities.
  • Knowledge of QA/QC and FDA/EMEA requirements essential.


Want to See 54,079 Jobs at Your Level?

BE THE FIRST TO HEAR ABOUT $100K+ POSITIONS FOR YOU - BEFORE THEY'RE FILLED!

Join TheLadders

As a member of TheLadders, you'll have access to:

  • The most senior-level jobs nationwide.
  • More than 35,000 executive and corporate recruiters.
  • Fortune 1,000 positions posted only on TheLadders.com.

You deserve a better way to search.
Join TheLadders today.

Similar Jobs at TheLadders.com

Sterilization Technology Manager - JBDIRSTER123009... - Boston, MA

Management Consultants - Global Practices - Boston, MA

Management Consultants - Life Sciences and HealthCare ... - Boston, MA