Senior Quality Manager, Ext Commercial Manuf - Bolton Landing, United States - XGen Pharmaceuticals DJB

Description

Job Title:
Senior QA Manager, External Commercial Manufacturing


Department:
Quality


Supervisor Title:
Director of Quality


Revision Date:
April 2024

This position is responsible for providing day to day quality input and oversight for successful life cycle of commercialized generic pharmaceuticals at external manufacturing partners globally and ensuring that the operational business is in compliance with cGMP, the Quality Agreement, regulatory requirements and X-GEN's Quality Management System.

The QA Manager, External Commercial Manufacturing will act as the lead quality point of contact for assigned commercialized Products.

Supports XGen DJB's Mission and Vision statement by adhering to the Code of Corporate Values and conforming to established performance expectations.

Independently manage and provide quality oversite as well as lead daily quality related interaction and commercial production execution with third parties and cross functional teams to assure:

Quality and compliance related matters meet appropriate GMP and regulatory requirements
Product is safe, pure and effective for distribution by direct review and inspection of the finished goods and documentation.
All documentation for release is present, accurate and within established ranges and specifications

Approval or rejection of product based on conformance to specifications, current Good Manufacturing Practices (cGMP's) requirements and /or contractual agreements.

Representation of the department and X-Gen on cross-functional teams and external business partner meetings
Compliance with cGMP's, regulatory, compliance requirements, and contractual agreements by developing and revising necessary company policies and procedures to support management of third-party contract manufacturers and external partners
High performance of third-party contract manufacturers by monitoring quality metrics and scorecard.

Work in collaboration with the XGen QA Manager of Supplier Quality and the Assigned CMO to resolve compliance issues by, but not limited to, overseeing implementation of CAPAs etc.

Supports XGen DJB's Operations related to commercial product distribution by:

Approving and releasing commercial product
Leading investigations associated with product non-conformances and deficiencies identified during inspections, manufacturing, and product complaints
Certifying that all incidents, complaints, and investigations are properly documented
Verifying corrective actions for prevention of reoccurrence are completed in a timely manner and are consistent with the stated corrective action
Investigating and determining the need for field alerts or recalls of company products manufactured by third party contract manufacturers

Reviewing and approving quality records/documentation from third parties, including but not limited to product and process change controls (e.g., master batch records, API, raw material, product specifications, analytical methods), stability and validation protocols/reports, quality incidents and investigation reports.

Perform on-site visits during manufacturing/packaging of X-GEN products and attend quality business reviews at external manufacturing partners to assess compliance with cGMPs and XGen's requirements
Participating in Agency and XGen inspections of external manufacturing partners to ensure successful inspection outcomes and maintain a constant state of inspection readiness at these sites
Performing quality risk assessments and driving risk reduction improvement plans and remediation where necessary
Driving quality compliance and performance metrics with external manufacturing partners and reporting metrics on a routine basis

Compliance with cGMP's, regulatory, compliance requirements, and contractual agreements by developing and revising necessary company policies and procedures to support management of third-party contract manufacturers and external partners
Develops staff and manages staff performance directed at evaluating and maintaining quality and talent pipeline if applicable
Monitors new regulatory legislation or guidelines which have direct impact on the business in relation to managing contractors.
Standardizes activities among all contractor manufacturing sites or specify the variations among sites.

Systematically provides for consultation, advisement, and assistance for site activity including support in review, approval, response drafting, and follow-up to audit reports.

Performs other related duties as assigned or directed.


Education:
Bachelor's Degree in science-Related (Biology, Microbiology, Pharmacy, Chemistry, Chemical or Quality Engineering) 5-8 years of work experience in Quality Assurance within the pharmaceutical industry or 3-5 years of experience working with pharmaceutical Contract Manufacturing Organizations (CMOs), Quality Control Laboratories, and business

Training (licenses, programs, or certificates):

ASQ Certified Auditor (desirable, not required)


Skills:
Basic/Moderate/Proficient

reading, writing, grammar, and mathematics skills

Basic/Moderate/Proficient

interpersonal relations and communication skills, including use of English language

Basic Moderate/Proficient

computer skills including Microsoft Office, Go To Meeting

Travel:

25% domestic and international travel required

Other Skills

Quality Assurance and Quality Control; cGMP; Contract Manufacturing (CMO); domestic and foreign regulations governing GMP plant operations and Relationship Management.

Must display in-depth understanding of FDA trends, FDA and EU regulations and guidelines


Experience:
Minimum: 15 years

Proficient: 20 years


Equipment:
Operate standard office equipment.


Physical Requirements:

Possess sufficient manual dexterity to be able to bend, sit, stand and reach with hands and arms; Visual and auditory skills required, including close vision, peripheral vision, depth perception and ability to adjust focus and ability to speak and hear.

The employee must regularly lift and/or move up to 10 pounds.


Compensation:
Position pays between $96,800 and $125,900 when a candidate is considered proficient.


Application Procedure:
For consideration, please visit the and join the talent community. You must submit an electronic cover letter and resume, along with salary requirements within the Career Center. Resumes and cover letters will be accepted until we have collected a sufficient number of qualified applicants.

Thank you for your interest in XGen Pharmaceuticals DJB, Inc.

XGen Pharmaceuticals DJB is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people.

EOE/AA.Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet
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