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Manager Commercial Quality

Date: Jul 10, 2019

Location: Coventry, RI, US, 02816

Company: Purdue Pharma L.P. & Affiliates

Job Summary

The Manager of Commercial Quality is a leader (of people & projects) for quality compliance activities related primarily to release of product to the commercial market, in accordance with GxP regulations and internal SOPs. 

Primary Responsibilities

Manage Quality Resources to accomplish day to day activities.

Develops Quality Team members by providing growth opportunities and assists with feedback on performance.

Primary responsibilities include the oversight of quality members that review and release of commercial batch records.

Responsible for overseeing quality related product launch activities.

Manages the Product Complaint Program.

With minimal direction reviews and approves GMP documentation such as Change Controls, Investigations, Planned Deviations, Specifications, and SOPs.

Reviews and approves equipment and facility qualification documentation.

Support Product Development and Regulatory Affairs for any new product submissions.

Approves/Participates in Technical Transfer activities.

Leads improvements/implementations of quality systems.

Performs auditing activities internally and with external vendors.

Education and Experience

A Manager of Commercial Quality should have a BS in chemistry or related field and  possess a minimum of 8-12 years relevant or equivalent level of experience in pharmaceutical or related industries, with demonstrated accomplishments in effectively implementing cGMP regulations, FDA and DEA regulations, and recent trends in validation concepts. The individual may have a “hands-on” knowledge of pharmaceutical manufacturing or laboratory equipment, and be able to monitor batch manufacture and instruct production operators as it relates to cGxP and GDP. Knowledge of pharmaceutical unit operations is desired, individual may have a primary focus such as solid dosage forms or oral solutions.

Alternatively, a graduate degree (MS preferred) with 6-10 years of relevant experience may be accepted or a PhD with 3-6 plus years of relevant experience.

Necessary Knowledge, Skills, and Abilities

Ability to manage team resources to meet day-to-day assignments.

Recognizes problems or compliance issues and reports them to Quality Management.

Exercises good judgment in interpreting, understanding context and reporting data.

Effectively identifies, describes, and communicates problem and impact in a timely manner.

Identifies, tracks and resolves issues to closure.

Identifies and resolves in-depth issues through collaboration with others.

Partners with colleagues in identifying and resolving potential compliance concerns.

Identifies and proposes opportunities for continuous improvement to quality systems.

Effectively performs root cause analysis and determines corresponding corrective measures.

Supervisory Responsibilities (if Applicable)

Ability to effectively assess internal and external talent.

Ability to effectively train colleagues.

Ability to mentor, coach and develop direct reports.

Provides ongoing balanced feedback on performance; writes and conducts performance appraisals.

Ability to resolve personnel issues.

Demonstrates ability to hold direct reports accountable, and assumes accountability for department or function.

Additional Information

Nearest Major Market: Providence
Nearest Secondary Market: Rhode Island

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