9 days old

Quality Associate Director

Kelly Services
Devens, MA 01434
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Quality Associate Director** at a prestigious Fortune 500 company working in **Devens, MA.**

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( ) however your resume must be received via the Submit Resume button included within.

**Job Title: Quality Associate Director**

**Pay: $100 per hour**

**Job description:**

Global Biologics Stability (GBS) manages the stability programs for commercial biologic Drug Substances and Drug Products. The global stability program supports all internal and external manufacturing sites. The contractor reports to the Associate Director of GBS and is responsible for stability product strategy and oversight of product stability programs. Activities include those associated with product stability strategy, stability program requirements, approval of stability protocols, and preparation, review and approval of stability reports and regulatory filings.

Candidate must have a full understanding of Biologic Molecules

**Major Duties and Responsibilities** :

Provide oversight and leadership to one or more commercial stability programs.

- Work in collaboration with Technical Product Teams, Global Regulatory Sciences, and manufacturing sites to develop stability product requirements for annual enrollments, process changes and investigations. Determine the stability requirements for each commercial product based on technical rationale and globally approved dossiers. Provide testing projections to the QC laboratories.

-Manage the stability book of work and ensure that stability activities are completed per site and brand timelines.

-Perform change control impact assessments and document the stability assessment in change controls. Review and endorse change controls as an expanded reviewer. Initiate change controls related to stability operations or product shelf life extension.

- Provide the technical requirements in a Master stability protocol, review and approve study specific protocols or batch enrollment forms. As needed, review and activate LIMS stability studies.

-Represent GBS on laboratory and manufacturing investigation teams. Perform stability impact assessments as required.

-Support stability evaluations by reviewing OOT assessments and process robustness presentations

-Support stability data reporting by authoring or reviewing Health Authority submissions and responding to Health Authority Queries. Point person for global rollout of observations that may affect stability programs and develop strategies to close gaps/mitigation.

-Approve, identify, write and revise stability procedures. Assist with development of company-wide Stability directives.

-Act, escalate, identify information regarding stability program that may impact lab capacity, product studies or regulatory commitments directly and promptly to management

-Identify and devise training need for ongoing stability activities. Ensure training requirements are met.

-Works according to cGMP requirements and HA expectations.

- Represent global stability in Health Authority inspections and internal quality audits

- Participate and/or lead OpEx initiatives to streamline and standardize management of stability programs.

- Develops staff strategic capability through coaching, and counseling.


Knowledge and Skill

-Minimum of 4 years (PhD)/ 10 years (MS)/ 12 years (BS) relevant cGMP experience in biopharma or other company

- Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a biologics manufacturing facility.

-Excellent written and verbal communication skills in communicating stability strategy to technical teams and in change control and investigations management system. Ability to work collaboratively in a team matrix environment is required.

- Significant experience with evaluating and interpreting stability data using statistics and statistics software.

- Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/ or Microbiology methods

-Exhibit strong leadership and decision making skills especially in problem solving and analytical thinking.

- Significant experience in Operational Excellence, with proven record of accomplishment in continuous improvement. Prior experience with commercial stability troubleshooting and demonstrated expertise in Biologics or Protein Therapeutic molecule

-Significant front room FDA/Inspectional experience on stability programs

Works independently, review data and demonstrated ability to recognize anomalous trends or results. Able to prioritize objectives from multiple projects and deliver according to overall strategy.- Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices; develops strategies for solving complex problems/issues; recommending and driving implementation of solutions. Use computer software/programs: Microsoft Office applications, SAP, LIMS, TrackWise, JMP, etc.

Decision Making

Contractor works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors.

-Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

-Acts as an advisor and mentor to stability staff

-Establishes and recommends changes to policies which affect subordinate organization.

-Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.

Supervision Received

Contractor receives assignments in the form of objectives and establishes goals to meet objectives.

Provides guidance to subordinates to achieve goals in accordance with establishes policies.

Work is reviewed and measured based on meeting established objectives and schedules.

Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions.

**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** at **.**

**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**

**Kelly Services is an Equal Opportunity Employer**

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at
Posted: 2021-01-08 Expires: 2021-02-08

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Quality Associate Director

Kelly Services
Devens, MA 01434

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