4 days old

Director, Ascoli Site Quality Operations

Ascoli Piceno, Marche 63100
**Role Summary** The Site Quality Operations Director partners with Site Operations to drive quality and compliance excellence through supplying quality products from the site which are compliant with regulatory requirements and meet customer needs. The role is accountable for the product quality, regulatory compliance, quality systems and related processes for the site. The scope of this role also includes quality budget and resource planning, quality performance metrics/quality dashboard, quality strategic planning, quality goals and objectives, and quality specific projects.

The role is accountable for providing leadership to the site in establishing compliance with marketing authorizations of all materials, packaging components, in-process and final commercial products with established specifications, compliance with regulations and other applicable standards. In addition, the incumbent builds talent and fosters colleague development, growing the leadership and capabilities of colleagues within QO and across the site organization. The position reports both to the Site Leader and to the GSM Regional Quality Operations Lead and is a member of the Site Leadership Team. Routine interactions occur with site leadership and above-site Quality Operations. The Site Quality Operations Leader will lead, manage and develop a diverse team of talented and engaged technical professionals with the responsibility of providing comprehensive support and guidance to all operations at the site in assuring Pfizer's Quality Standards are met.

The position will have financial accountability for providing input into the site budget and managing the Quality portion of the site budget.

The position directly manages 4 Team Leaders and a total organization of approx. 120 colleagues.

**Role Responsibilities**

This position will:

1) Identify quality, process, and GMP problems and assure resolution.

2) Manage overall process in evaluating site compliance to Pfizer Quality Standards (PQS) and implement appropriate actions.

3) Manage the overall assurance and disposition of products produced at the manufacturing site or by approved vendors.

4) Approve quality operations and production quality assurance reports and investigations for deviations from approved manufacturing processes or specifications.

5) Review key quality and regulatory documentation and implement appropriate actions.

6) Lead and engage the site quality review team (SQRT) and AQRT process to ensure site regulatory compliance to ensure marketed product quality. Responsibility for site regulatory inspections.

7) Coordinate development of area training plans in order to manage the training, qualifications and educational needs of the Quality Operations colleagues. Manage talent development to assure adequate current capabilities and future succession for critical positions.

8) Develop and maintain an organizational structure consistent with the area needs and goals, including the preparation and administration of annual performance assessments and discussions.

9) Optimize site effectiveness and efficiency to ensure site performance goals are achieved or exceeded without compromising quality and compliance.

10) Provide strategic leadership to QO and to the site on quality.

11) Be a voice for change and continuous improvement.

12) Leads Change; Holds people accountable; and Builds Effective Teams.

**Organizational Relationship** Role will manage site Quality organization and be part of the site leadership team. Role will interact with Global Quality and cross functional disciplines within the Pfizer network.

**Financial Accountability** The Quality Unit leader is responsible for maintaining the quality unit organization budget and working closely with the site leader.


This position reports to the GSM Regional Quality Operations Lead and the Site Leader. This position leads the Site Quality Operations function and directly manages Site Quality Operations unit leaders. Includes direct & indirect reports, matrix responsibility and or additional resources (i.e. contingent workers), as applicable.

This position has to be able to make decisions independently with a compliance mindset. This position needs to be able to communicate effectively to senior management and the manufacturing leadership team. Decisions need to be fact based and of quality mindset.

**Basic Qualifications**

Minimum of 10 years related pharmaceutical experience and 5 years quality operations experience with minimum of B.S. in a Science related fields such as degree in Chemistry, Microbiology, Pharmacy or Chemical Engineering. Demonstrated capability of managing managers and teams.

**Preferred Qualifications**

Advanced degree in pharmaceutical science, biology, chemistry, engineering or related science.

At least 15 years work experience in the pharmaceutical Industry preferably within different functions within Operations and/or Quality & Compliance, with 10 years of supervisory experience, preferably at multiple sites.

Experience in at least two quality and/or science areas, working in functions outside Quality/EHS, e.g. Technology, Validation, Operations, Regulatory, working with other manufacturing and R&D sites to understand a broader perspective.

Exposure to Regulatory inspections. Evaluating and continuously improving site Quality Systems.

Demonstrated knowledge and applicability of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices and systems.

Has demonstrated leadership management, coaching, development and technical capabilities.

Strong verbal, written, presentation and interpersonal communication skills.

Proven ability to plan, implement, and achieve significant, complex goals and objectives.

Demonstrated commitment to achieving objectives in a manner that is supportive of Pfizer Values and PGS mission elements. Desirable to have exposure to Lean, Six Sigma and Transformation.

Knowledge of Italian language is preferred.

AIFA QP certification or the technical competencies to be certified as QP by AIFA is desirable.

**Other information** Relocation package offered to suitable candidate.

Minimum business travel. Travel is possible up to 5% of the time.


Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control


Posted: 2020-10-14 Expires: 2020-11-13

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Director, Ascoli Site Quality Operations

Ascoli Piceno, Marche 63100

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