Director Quality

Lawrence Harvey


Job ID :

12052


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

North America,--Kentucky,Kentucky,


Key Skills :

Kentucky , USA , PHARMACEUTICALS , Director - Pharma , Fill Finish (aseptic) , GMP , Quality


Salary :

Negotiable


Date Posted :

29 Jun, 2018



Company Name :

Lawrence Harvey


Location1 :

Kentucky




Job Category :

Quality Assurance Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

POSITION SUMMARY

The Director of Quality is a strategic partner to the management team at Piramal Pharma Solutions Lexington (PPS). This Senior Level role must be able to articulate and achieve clear objectives as well as sound and effective processes. This role is responsible for leading and supervising quality strategy and execution within the company to direct good practices reducing risks on development of new technologies and collaborative projects within the organizational portfolio. This individual will work closely with the leadership team to foster, direct, and continually improve quality throughout the organization as well as cost and time factors consistent with PPS business objectives. Coverage of responsibility includes Quality Assurance, Document Systems, Quality Control, and Microbiology.

PRIMARY RESPONSIBILITIES
Ensure compliance with applicable internal and external regulations, standards, policies, and procedures related to quality and regulatory status and performance of company operations, processes, and products.
Represent company as the primary liaison with involved external regulatory and standards bodies (e.g. Food and Drug Administration-FDA). When necessary, adjudicate issues with product submissions, product performance, compliance concerns, and prevailing/impending regulatory requirements.
Represent company as the primary liaison with involved client quality audits. When necessary, adjudicate issues with client and PPS quality systems. Represent PPS Quality Assurance department in project meetings.
Responsibility for the identification and escalation of emerging company compliance trends within organization; assist in developing strategies to mitigate or remediate trends.
Provide updates and recommendations to company quality council and company senior management staff with regard to status of such quality and compliance strategies, projects, and goals as related to cross-functional business objectives.
Work closely with the leadership team to foster and direct quality throughout the organization continually improving quality. Lead the quality culture of PPS by effectively utilizing departmental resources.
Responsible for development and execution of quality strategies and objectives within the organization.
Focus management on the appropriate metrics and actions based on those metrics across the organization assuring effective tracking of operational performance.
Ensure internal audit program is adequately defined and followed (inclusive of comprehensive CAPA development, approval, and execution) in a timely and effective manner.
Conduct external audits as required.
Ensure product is released in a timely manner in compliance with company procedures and regulatory requirements.
Define and approve departmental budget and capital expenditures.
Exercise independent action in hiring and firing personnel within established company policy and procedures.
Lead and mentor quality assurance and document system staff.
Ensure PPS document control is within regulatory and company policies and procedures.
Attendance of industry conferences to stay informed of current industry trends and expectations is required.
Continually seek industry recognized certifications such as CQA, CPGP, or RAPS.

QUALIFICATIONS
Bachelor of Science Degree in a related field, advanced degree preferable
A minimum of ten years' experience in pharmaceuticals
Extensive experience in Aseptic/Parenteral pharmaceuticals is required
FDA auditing experience mandatory.
Background in global QS and international management recommended.

WORK ENVIRONMENT
High demanding office setting spending extended time in client meetings.
Position may require extended hours including evenings and weekends, travel to multiple work sites, and
occasional out-of-town travel.

ACKNOWLEDGEMENT

NOTE: The above statements are intended to describe the general nature of work performed by the Director of Quality. These statements are not to be construed as an exhaustive list of all responsibilities, tasks, and skills required of an employee in this position.

Piramal Pharma Solutions Lexington (PPS) reserves the right to require other tasks be performed when warranted (for example, by emergencies, changes in personnel or workload, corporate reorganization, or technical development). PPS also reserves the right to revise this position description.


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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