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Transport Qualification and Compliance Manager


Collegeville, PA
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Job Details

Job Title Transport Qualification and Compliance Manager

JobID 1612997

Location: Collegeville, PA

Description **ROLE SUMMARY**

The Implementation Lead will be responsible for the following:

+ Developing country requirements listing derived from regulatory queries/responses from product MLA/BLA and MOH/BOH inspections

+ Being the lead project management SME for NPL and regulatory compliance-related activities

+ Leading cross functional team of subject matter experts (SME's) across R&D and commercial operations as part of Biologic launch activities

+ Developing long-term strategies to manage global NPL of biologic products, and identify continuous improvement for improving speed to market.

+ Responsible for obtaining cross functional requirements for the development of new product launch strategies

+ Development of technical transfer strategies to deploy/implement identified thermal systems throughout Pfizer transportation network

+ Developing project management plans on a product-by-product basis to ensure global readiness for new product launch activities

+ Lead SME for deployment of new packaging systems within intercompany operations network

+ Leading RFI/RFP/RFQ with Global Procurement for newly identified systems

+ Maintenance of the IO Global Re-use continuous improvement program, and other packaging-relate CIP's


**New Product Launch (NPL) Support:**

+ Work closely with global regulatory, markets, and IO Customer service, to develop process for consolidating regulatory queries and responses, and incorporating as part of NPL development activities

+ Will become integrated with DP and DP Sub Teams, and take part in product development meetings to align upstream and downstream launch activities

+ Conduct weekly meetings with NPL X-functional teams to ensure launch matrix is up to date with latest development strategies and launch timing

+ Conduct weekly and ad hoc meetings with regional LSC/LNO SME's to develop and deploy logistics strategies for launching biologic products globally

+ Attend Pfizer Connect NPL and process change meetings as LSC lead to incorporate as part of overall launch strategy

+ Develop strategy for developing technical transfer activities to deploy logistics solutions to markets and sites systematically and under controlled conditions

+ Accountable for completion and filing of User Requirement Specification (URS) for all NPL's and Transport Validation Support requests

**Validation and qualification support**

+ When required, will author operational, performance qualification protocols and reports.

+ Responsible for drafting technical documentation supporting qualification strategies established by LSC launch or regional leads

+ Ensures logistics compliance with regional regulatory requirements where accountable

+ Responsible for completion and filing of User Requirement Specification (URS) for all NPL's and Transport Validation Support requests


+ BS in Packaging/Mechanical or related Engineering. Advanced Degree desirable

+ 3-5 years of experience in Package Engineering or equivalent Technical Packaging Project Management

+ 3-5 years of experience as project manager with experience working with regulatory bodies

+ Experience and knowledge of the Pharmaceutical environment

+ Expertise in identification, qualification and selection of Packaging Materials and Technologies for temperature sensitive products

+ Candidate must have excellent communication and presentation skills

+ Experience and knowledge of latest cold chain packaging technologies/trends

+ Aptitude to learn, develop, and adapt to change

+ Effective communication skills, both oral and written (English) with both technical and non-technical clients. Demonstrated collaborative, consultative, problem solving, prioritization and analytical skills


**Technical skills**

+ Demonstrated skills as a project lead with the ability to drive results with stakeholders of varying levels

+ In depth knowledge of a broad range of controlled temperature shipping components, systems, monitoring equipment, best practices and governing regulations

+ In depth understanding of regulatory guidelines impacting the launch of biologic product applications and launch on a global basis

+ General understanding of biologic drug development and commercialization process

+ Understanding of processes used in development and qualification of controlled temperature shipping systems

+ Proven project management and complex problem solving skills

+ Ability to effectively manage and influence cross functional teams

+ Effective verbal and written communication and technical writing skills

+ Can determine areas of potential risk to business success and generate gap analysis

**Technical functional skills :**

+ Can analyze operational process problems and provide support in determining appropriate corrective and preventative actions

+ Demonstrate knowledge through practical application

+ A propensity to pursue goals with energy and persistence

+ Ability to lead meetings with senior-level personnel and can articulate issues and solutions to both team and senior management.

+ Maintains clear communication with customers (internal and external) and monitors customer expectations

**Interpersonal skills :**

+ Strong leadership acumen with the ability to lead cross functional meetings to drive strategic decision-making

+ Must be detailed oriented with the ability to translate regulatory requirements into logistics strategy

+ Ability to work with multi-cultural teams and collaborative environment

+ Ability to work in a matrixed organization

+ Interacts with others in a transparent, honest and authentic fashion. Ensures stakeholders are confident of one's intentions as well as those of the organization

+ Understands and acknowledges the differing needs of stakeholders and works to achieve success in a mutually beneficial manner

+ Highly organized and ability to prioritize activities on a daily basis

**Communication skills :**

+ Ability to translate technical and operational issues into summary level updates

+ Ability to communicate ideas in both technical and user-friendly language

+ Excellent written and oral communication skills are a must


+ Must be able to work in a global environment across multiple time zones

+ Up to 25% travel


+ Telecommuting will be considered for the right candidate

**EEO Statement**

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**Additional Offer Details:**

+ **Last Date to Apply for Job: September 26, 2017**

+ **Grade:11**

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

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

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