bolthires & Co. – Senior Specialist, Quality Systems and Compliance – West Point, PA

Job title:Senior Specialist, Quality Systems and ComplianceCompany: bolthires & Co. Job description: Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.We are seeking a Growth and Improvement mindedSenior Supplier Quality Management Specialist that can help drive our Strategic Operating Priorities. Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical NeedsExecute | Prioritize Resources BehindOur Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While OptimizingOur Base Business)Adapt | DevelopOur People, Culture and Business Model to Evolve with a Dynamic LandscapeDiverse Talent | We are dedicated to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the worldValues and Standards |Our Steadfast Dedication toOur Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental toOur Success – They are a Competitive Advantage for UsStrategic SummaryTheSenior Supplier Quality Management Specialist supports and reports to the Director, Supplier Quality Management (SQM) and is expected to provide expertise on Quality processes and systems to the SQM organization on an ongoing basis to remediate and optimize supplier Quality and Compliance performance.Accountable for compiling, authoring, and analyzing supplier Quality Agreements and associated Standard Operating Procedures, where applicable and will serve as the primary SQM author for these documents and will ensure alignment with our Company site, functional stakeholders and SQM. The incumbent will have an expertise in external regulatory requirements, internal Quality standards/requirements and technical writing. Key FunctionsWork independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | InclusionWorking in collaboration with suppliers and our Company using sites, negotiates, authors, and obtains approval for supplier Quality Agreements (QAs)In lieu of an IT solution for QAs, maintains the QA library, a comprehensive listing of all supplier QAs in the network.Ensures proper linkage in Supplier TransparencyServes as primary SQM contact for IT solution currently in development for QA processServes as a Subject Matter Expert (SME) for Topic 2.3, External Entities, as it pertains to Quality Agreement Template content and related SOPs, Work Instructions, and other Quality Management System (QMS) documents | Works closely with Topic 2.3 sub system owner to address questions from using sites and provide guidanceProvides support to our Company using sites and functions during regulatory inspections or Company internal audits, as requested per area of expertiseGenerates periodic metrics across functional support areas.Provides monthly input for SQM Staff Meetings regarding QA metrics, key accomplishments, and items for escalationMaintains proficiency using various databases such as Supplier Transparency (ST) and MIDASConducts problem-solving events using lean six sigma toolsParticipates in external benchmarking and internal voice of customer analyses for best practices managementEducationBachelor degree in engineering, science, or related area of studyRequiredFive years in Quality, Technical, or Operations role (s)Thorough knowledge of cGMPsEffective technical writing, analytical and computer skills, including software packages used in the maintenance and analysis of dataPreferredPrior experience with negotiating and authoring Quality AgreementsAbility to work in a virtual, global environment and participate or lead virtual meetings that may occur during off-hours, accommodating multiple time zonesProven self-starter: able to multi-task and work independently to complete assignmentsExperienced negotiations skillsPossesses excellent interpersonal, inclusion, and communication skillsAppreciates and respects diversity, cultures, and normsFacilitates business negotiations in a professional mannerExperience using Supplier Transparency and familiarity with supply chainsAbility to work within a matrix organization and leverage expertise from other of our Company functions and departmentsOur Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide.Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every timeWho we are …We are known as bolthires & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for …Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today. NOTICE FOR INTERNAL APPLICANTSIn accordance with, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Residents of Coloradoto request this role’s pay range. New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.Current Employees applyCurrent Contingent Workers applyUS and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process. For more information about personal rights under Equal Employment Opportunity, visit:We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Residents of Colorado:Click to request this role’s pay range. Search Firm Representatives Please Read Carefullybolthires & Co., Inc., Rahway, NJ, USA, also known as bolthires Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.All bolthires / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please apply no phone calls or emails. Employee Status: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: No Travel RequiredFlexible Work Arrangements:Remote WorkShift: 1st - DayValid Driving License: NoHazardous Material(s):Number of Openings: 1Expected salary:Location: West Point, PAApply for the job now!Apply tot his job