1+ months

DPM Compliance Lead

Pfizer
Groton, CT 06340
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**Why Patients Need You**



Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.



**What You Will Achieve**



We are seeking a highly motivated individual for the role of Compliance Lead - Drug Product Manufacturing at our Solid Dose Manufacturing facilities in Groton, CT.The successful candidate will work effectively across inter-disciplinary teams to support all aspects of compliance across Drug Product manufacturing- partnering with Quality organization, EHS and other DPS compliance leads. The role will initiate and lead improvement projects associated with Pfizer Quality System and EHS standards ensuring operational efficiency and compliance needs for DPM and the broader DPS organization.



The candidate will work closely with internal DPM groups (Drug Product Manufacturing Leads, Technical Support, Technical Services, Drug Product Supply (DPS) colleagues and collaboratively with Quality Operations, Analytical, EHS, and Training. The successful candidatemust demonstrate strong teamwork dynamics when interfacing with various groups.



**How You Will Achieve It**



**ROLE RESPONSIBILITIES**



+ Leads Cleaning Validation program for GRO-DPM. Maintains Cleaning Validation Master Plan. Leads CV Risk Assessments, CV Protocols and overall CV Strategy.

+ Serve as primary Groton DPS contact to PS Training and PS Learning Community

+ Assure departmental compliance to job function curricula, job description, and CV documentation expectations

+ Serve as a "Trained Trainer" for Groton-based DPS functions

+ Be a key DPS advocate for training and provide DPS voice to Pharm Sci learning activities

+ Responsible for ensuring cohesive training is developed and delivered.

+ Responsible for the overall operational compliance ensuring that the ways of working enable efficient site operations and that clinical and development needs of DPS are met.

+ Leads DPM compliance meetings/ processes to ensure efficient, safe and securely manage GMP operations.

+ Collaborate across DPS to evaluate and implement best practice opportunities.

+ Leads on improvement projects and delivers implementation effectively.

+ Seeks relevant updates on GMP and EHS guidelines and interprets application and effective implementation.

+ Responsible for GMP and EHS oversight for DPM, including leading self-inspections, maintaining risk assessments, PQS reviews, SOPs and progressing change controls and actions.

+ Take lead role in deviation reporting and identifying relevant preventive and corrective actions.

+ Provide lead on DPM GMP and EHS strategy and development.

+ Originate and implement or oversee delivery of projects associated with compliance, operational efficiency and organizational needs.

+ Assure steady state inspection readiness for Groton DPM.

+ Support and lead audit preparation activities and coordination with quality organization; lead/facilitate audit responses and plans

+ Develop a local internal audit plan for DPSS and Groton SDM including document checks and walk-throughs

+ Reporting to the Head of Groton Drug Product Manufacturing Will oversee others in matrix reporting structure

+ Support DPS EHS committee and Groton Site EHS committee.

+ Develop proactive EH&S approach for Groton DPM including facility and office space work environments

+ Take ownership of and lead updates to Groton DPM Business Continuity Plans



**Qualifications**



**Must-Have**



+ Extensive experience within a GMP regulatory role with strong understanding of all compliance aspects of Drug Product Manufacturing.

+ Required to take lead role and make decisions in ambiguous situations. Strong continuous improvement background with excellent interpersonal skills.

+ Able to develop and build strong teams to deliver against objectives.

+ Proven ability to formulate and implement more effective and robust compliance process in a drug product environment.

+ **Demonstrated ability to learn new computerized systems and skills**

+ BS degree in chemistry/Biology or chemical/bio-medical/mechanical/industrial engineering or equivalent with 10+ years of previous pharmaceutical GMP experience.

+ Excellent verbal and written communication skills.

+ Strong interpersonal skills and accountability in day-to-day interactions with an operational focus on business goals, customers and process required

+ Teamwork spirit, good communication skills and training abilities



**Nice-to-Have**



+ Experience with Cleaning Validation programs

+ Experience with Equipment Qualification and Validation Programs

+ Strong knowledge of Computerized Systems, Compliance regulations and standards

+ Experience with with QTS software system

+ Previous experience deploying technology in manufacturing environments (GMP Preferred).



Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.



**PHYSICAL/MENTAL REQUIREMENTS**



+ Standing, walking, bending, climbing, reaching, and lifting upward of 55 pounds may be required.

+ Personal Protective Equipment such as gloves, a full Tyvek suit and breathable air or filtering face piece may be required.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



+ Role requires a Groton on-site presence. Off-shift and weekend work may be required.

+ In addition, the Groton DPS Compliance Lead will collaborate closely with the Sandwich Compliance and Training Leads to identify DPS wide alignment opportunities and best practices.



+ \#LI-PFE

**Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.**



**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.



**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.



Manufacturing



\#LI-PFE
Posted: 2021-11-10 Expires: 2022-02-10
Sponsored by:
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DPM Compliance Lead

Pfizer
Groton, CT 06340

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